FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K200721 |
Abbott (St. Jude Medical) |
Agilis HisPro Steerable Catheter With Electrodes |
06/03/2020 |
K220340 |
Abbott Medical |
Amplatzer Steerable Delivery Sheath |
03/09/2022 |
K212026 |
Abbott Medical |
Amplatzer Steerable Delivery Sheath |
09/27/2021 |
K212738 |
Abbott Medical |
Amplatzer Talisman Delivery Sheath |
09/27/2021 |
K190581 |
Abbott Medical |
Amplatzer Trevisio Intravascular Delivery System |
04/05/2019 |
K232690 |
Abbott Medical |
AmuletÖ Steerable Delivery Sheath |
09/29/2023 |
K221750 |
Abbott Medical |
CPS AIM Universal II Slittable Inner Catheter |
06/30/2022 |
K231311 |
Abbott Medical |
CPS DirectÖ Universal slittable outer guide catheter (DS2C029) |
06/02/2023 |
K121352 |
Abbott Vascular |
ARMADA 14XXT PTA CATHETER |
08/15/2012 |
K014118 |
ABBOTT VASCULAR INC. |
MODIFICATION TO SUPERCROSS CATHETER |
01/11/2002 |
K001856 |
ABBOTT VASCULAR INC. |
SUPERCROSS CATHETER |
03/07/2001 |
K090509 |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER |
03/20/2009 |
K181563 |
Access Scientific, LLC |
The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology |
09/26/2018 |
K171176 |
Acrostak (Schweiz) AG |
M-CATH Microcatheter |
09/15/2017 |
K062084 |
ACUMEN MEDICAL, INC. |
7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 |
08/18/2006 |
K070051 |
ACUMEN MEDICAL, INC. |
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM |
04/06/2007 |
K042381 |
ACUMEN MEDICAL, INC. |
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 |
12/28/2004 |
K994229 |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
VERIPATH PERIPHERAL GUIDING CATHETER |
02/25/2000 |
K130525 |
ADVANCED CATHETER THERAPIES, INC. |
OCCLUSION PERFUSION CATHETER |
10/03/2013 |
K070238 |
AGA MEDICAL CORP. |
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM |
02/28/2007 |
K093476 |
AGA MEDICAL CORP. |
AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 |
02/05/2010 |
K083214 |
AGA MEDICAL CORP. |
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 |
05/12/2009 |
K091793 |
AGA MEDICAL CORP. |
AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 |
07/09/2009 |
K072313 |
AGA MEDICAL CORP. |
AMPLATZER TORQVUE DELIVERY SYSTEM |
11/02/2007 |
K080994 |
AGA MEDICAL CORP. |
AMPLATZER TORQVUE EXCHANGE SYSTEM |
05/16/2008 |
K080757 |
AGA MEDICAL CORP. |
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM |
04/18/2008 |
K120120 |
AGA MEDICAL CORPORATION |
AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH |
03/15/2012 |
K121611 |
AGA MEDICAL CORPORATION |
AMPLATZER TORQVUE FX |
08/23/2012 |
K163000 |
AGA Medical Corporation (Wholly Owned by St. Jude Medical Co |
AMPLATZER TorqVue 45x45 Delivery Sheath |
12/23/2016 |
K162228 |
AGA MEDICAL CORPORATION (WHOLLY OWNED BY ST.JUDE MEDICAL COR |
TorqVue Low Profile Delivery Catheter |
09/09/2016 |
K141529 |
ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S |
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER |
12/03/2014 |
K051060 |
ANGIODYNAMICS, INC. |
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER |
05/26/2005 |
K062609 |
ANGIODYNAMICS, INC. |
MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER |
10/06/2006 |
K032069 |
ANGIODYNAMICS, INC. |
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
08/27/2003 |
K111750 |
ANGIOSLIDE, LTD |
EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
07/21/2011 |
K171146 |
Arrow International, Inc. (Subsidiary of Telelflex Inc.) |
Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. |
06/23/2017 |
K093050 |
ARROW INTL., INC. |
ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 |
12/18/2009 |
K021120 |
ARROW INTL., INC. |
RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP |
05/02/2002 |
K984482 |
ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC. |
AVE GL-1 GUIDING CATHETER |
07/30/1999 |
K152447 |
ASAHI INTECC CO., LTD. |
ASAHI Caravel |
01/22/2016 |
K152249 |
ASAHI INTECC CO., LTD. |
ASAHI Corsair Armet |
03/04/2016 |
K161362 |
Asahi Intecc Co., Ltd. |
ASAHI Corsair Armet |
06/14/2016 |
K202252 |
Asahi Intecc Co., Ltd. |
ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), |
09/08/2020 |
K151103 |
ASAHI INTECC CO., LTD. |
ASAHI Corsair Microcatheter |
06/23/2015 |
K083127 |
ASAHI INTECC CO., LTD. |
ASAHI CORSAIR MICROCATHETER |
02/03/2009 |
K161126 |
ASAHI INTECC CO., LTD. |
ASAHI Corsair Pro |
08/25/2016 |
K182420 |
Asahi Intecc Co., Ltd. |
ASAHI Corsair Pro XS |
12/20/2018 |
K192782 |
Asahi Intecc Co., Ltd. |
ASAHI CROSSWALK Peripheral Support Catheter |
11/29/2019 |
K141981 |
ASAHI INTECC CO., LTD. |
ASAHI FUBUKI 043 / ASAHI FUBUKI |
03/09/2015 |
K061601 |
ASAHI INTECC CO., LTD. |
ASAHI PRECIOUS GUIDE CATHETER |
11/17/2006 |
K182844 |
Asahi Intecc Co., Ltd. |
ASAHI SASUKE |
06/22/2019 |
K051772 |
ASAHI INTECC CO., LTD. |
ASAHI TORNUS SUPPORT CATHETER |
09/26/2005 |
K060745 |
ASAHI INTECC CO., LTD. |
ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY |
06/23/2006 |
K091188 |
ASAHI INTECC CO., LTD. |
ASAHI ZENYTEEX GUIDING CATHETER |
02/26/2010 |
K072316 |
ASAHI INTECC CO., LTD. |
PRECIOUS PLUS GUIDE CATHETER |
09/17/2007 |
K132556 |
ASAHI INTECC CO., LTD. |
SHEATHLESS EAUCATH CORONARY GUIDE CATHETER |
10/24/2013 |
K062885 |
ASAHI INTECC CO., LTD. |
STRIDE MICROCATHETER |
06/13/2007 |
K203521 |
Ashitaka Factory of Terumo Corporation |
FineCross M3 |
03/03/2021 |
K161546 |
ASHITAKA FACTORY OF TERUMO CORPORATION |
R2P SlenGuide |
10/14/2016 |
K061680 |
ATRIUM MEDICAL CORP. |
ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER |
12/15/2006 |
K093431 |
ATRIUM MEDICAL CORP. |
CLEARWAY OTW MODEL 85912 |
04/20/2010 |
K113112 |
ATRIUM MEDICAL CORP. |
CLEARWAY RX NB CATHETER |
11/17/2011 |
K111704 |
AVINGER, INC. |
AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX |
09/09/2011 |
K112579 |
AVINGER, INC. |
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER |
10/06/2011 |
K101647 |
AVINGER, INC. |
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 |
08/06/2010 |
K102022 |
AVINGER, INC. |
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S |
08/06/2010 |
K083313 |
AVINGER, INC. |
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER |
02/02/2009 |
K973371 |
B. BRAUN MEDICAL, INC. |
CERTODYN RAECG UNIVERSAL ADAPTER |
11/24/1997 |
K182918 |
Balt USA LLC |
Ballast 088 Long Sheath |
03/21/2019 |
K052236 |
BARD PERIPHERAL VASCULAR, INC. |
BARD ATLAS PTA BALLOON DILATATION CATHETER |
08/23/2005 |
K072283 |
BARD PERIPHERAL VASCULAR, INC. |
DORADO PTA BALLOON DILATATION CATHETER |
09/19/2007 |
K103367 |
BARD PERIPHERAL VASCULAR, INC. |
SEEKER CROSSING SUPPORT CATHETER |
12/08/2010 |
K161986 |
BARD PERIPHERAL VASCULAR, INC. |
SIDEKICK and USHER Support Catheters |
08/04/2016 |
K101117 |
BAYLIS MEDICAL CO., INC. |
LEV-OR DILATION CATHETER OTW |
07/16/2010 |
K192774 |
BioCardia |
BioCardia 8F Morph DNA Deflectable Guide Catheter |
01/07/2020 |
K042553 |
BIOCARDIA, INC. |
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER |
02/17/2005 |
K962717 |
BIOCOMPATIBLES CARDIOVASCULAR, INC. |
6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING |
02/12/1997 |
K193474 |
BIOTRONIK, Inc |
Selectra 3D Outer Guiding Catheters |
10/16/2020 |
K192996 |
Biotronik, Inc |
Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool |
11/21/2019 |
K082933 |
BIOTRONIK, INC. |
PASSEO-35 PTA CATHETER |
11/03/2008 |
K033217 |
BIOTRONIK, INC. |
PHERON PTA CATHETER |
10/31/2003 |
K033320 |
BIOTRONIK, INC. |
SCOUT PRO |
11/19/2003 |
K060807 |
BIOTRONIK, INC. |
SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM |
04/24/2006 |
K093303 |
BIOTRONIK, INC. |
SCOUTPRO 7F LONG CATHETERS |
11/20/2009 |
K072329 |
BIOTRONIK, INC. |
SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED |
03/25/2008 |
K060655 |
BIOTRONIK, INC. |
SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H |
04/04/2006 |
K101776 |
BIOTRONIK, INC. |
SCOUTPRO ACS |
07/23/2010 |
K080988 |
BIOTRONIK, INC. |
SCOUTPRO CS LEAD INTRODUCER SYSTEM |
05/07/2008 |
K101282 |
BIOTRONIK, INC. |
SCOUTPRO HEMOSTATIC VALVE |
07/21/2010 |
K071665 |
BIOTRONIK, INC. |
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 |
07/18/2007 |
K123324 |
BIOTRONIK, INC. |
SELECTRA 7F CATHETERS |
01/11/2013 |
K111839 |
BIOTRONIK, INC. |
SELECTRA ACCESSORY KIT |
09/26/2011 |
K131978 |
BIOTRONIK, INC. |
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL |
08/23/2013 |
K151409 |
BIOTRONIK, INC. |
Selectra Catheters and Selectra Accessory Kit |
08/07/2015 |
K183265 |
Biotronik, Inc. |
Selectra Catheters, Selectra Accessory Kit |
12/13/2018 |
K110461 |
BIOTRONIK, INC. |
SELECTRA CS LEAD INTRODUCER SYSTEM |
04/20/2011 |
K111154 |
BIOTRONIK, INC. |
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 |
05/23/2011 |
K222037 |
Biotronik, Inc. |
Selectra Lead Implantation System |
07/19/2022 |
K112482 |
BIOTRONIK, INC. |
SELECTRA SLITTER TOOL |
09/26/2011 |
K020028 |
BOSTON SCIENTIFIC |
6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX |
01/22/2002 |
K132914 |
BOSTON SCIENTIFIC |
ACUITY PRO LEAD DELIVERY SYSTEM |
04/03/2014 |
K123765 |
BOSTON SCIENTIFIC |
GUIDEZILLA GUIDE EXTENSION CATHETER |
03/19/2013 |
K112303 |
BOSTON SCIENTIFIC |
RUBICON SUPPORT CATHETER |
11/09/2011 |
K231176 |
Boston Scientific |
Stingray LP Catheter |
05/25/2023 |
K180864 |
Boston Scientific |
WATCHMAN TruSeal Access System |
07/20/2018 |
K963663 |
BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES |
11F GUIDING CATHETER |
01/13/1997 |
K010874 |
BOSTON SCIENTIFIC CORP. |
6F MACH 1, MODEL 34356-XXX |
06/21/2001 |
K111252 |
BOSTON SCIENTIFIC CORP. |
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F |
06/02/2011 |
K033441 |
BOSTON SCIENTIFIC CORP. |
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER |
11/21/2003 |
K021721 |
BOSTON SCIENTIFIC CORP. |
EQUALIZER BALLOON CATHETER |
06/20/2002 |
K042568 |
BOSTON SCIENTIFIC CORP. |
EXCELSIOR 1018 AND SL-10 MICROCATHETERS |
10/15/2004 |
K062202 |
BOSTON SCIENTIFIC CORP. |
OCCLUSION BALLOON |
10/20/2006 |
K122394 |
BOSTON SCIENTIFIC CORP. |
RUBICON 18 SUPPORT CATHETER |
08/30/2012 |
K053118 |
BOSTON SCIENTIFIC CORP. |
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX |
12/16/2005 |
K053116 |
BOSTON SCIENTIFIC CORP. |
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX |
12/16/2005 |
K050599 |
BOSTON SCIENTIFIC CORP. |
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER |
06/03/2005 |
K011889 |
BOSTON SCIENTIFIC CORP. |
ULTRA -THIN SDS BALLOON DILATATION CATHETER |
12/21/2001 |
K050389 |
BOSTON SCIENTIFIC CORP. |
ULTRA-SOFT SV BALLOON DILATATION CATHETER |
05/25/2005 |
K171612 |
Boston Scientific Corporation |
ACUITY Pro Lead Delivery System |
06/30/2017 |
K163314 |
Boston Scientific Corporation |
Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter |
03/23/2017 |
K171452 |
Boston Scientific Corporation |
MAMBA and MAMBA FLEX Microcatheters |
08/21/2017 |
K190401 |
Boston Scientific Corporation |
MAMBA and MAMBA Flex Microcatheters |
03/15/2019 |
K060572 |
Boston Scientific Corporation |
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM |
03/15/2006 |
K062594 |
Boston Scientific Corporation |
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM |
09/20/2006 |
K171913 |
Boston Scientific Corporation |
Rubicon 14, 18 and 35 Support Catheters |
07/25/2017 |
K223633 |
Boston Scientific Corporation |
RubiconÖ Control Support Catheter (H749394323506A1) |
08/08/2023 |
K152401 |
BOSTON SCIENTIFIC CORPORATION |
Stingray LP Catheter |
12/04/2015 |
K212228 |
Boston Scientific Corporation |
WATCHMAN FXD Curve Access System |
08/13/2021 |
K021735 |
BOSTON SCIENTIFIC SCIMED, INC. |
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER |
08/08/2002 |
K980453 |
BOSTON SCIENTIFIC SCIMED, INC. |
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS |
08/11/1998 |
K981413 |
BOSTON SCIENTIFIC SCIMED, INC. |
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS |
05/13/1998 |
K013789 |
BOSTON SCIENTIFIC, TARGET |
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 |
12/06/2001 |
K010853 |
BOSTON SCIENTIFIC, TARGET |
GUIDER SOFTIP GUIDING CATHETER XF 5F |
04/18/2001 |
K102725 |
BRIDGE MEDICAL, INC. |
CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M |
05/10/2011 |
K113589 |
BRIDGEPOINT MEDICAL |
BIGBOSS CATHETER |
01/04/2012 |
K091841 |
BRIDGEPOINT MEDICAL |
BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 |
09/02/2009 |
K081130 |
BRIDGEPOINT MEDICAL |
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER |
05/14/2009 |
K111963 |
BRIDGEPOINT MEDICAL |
BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER |
08/10/2011 |
K080987 |
BRIDGEPOINT MEDICAL |
BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES |
02/06/2009 |
K120129 |
BRIDGEPOINT MEDICAL |
MANTARAY CATHETER |
02/03/2012 |
K101591 |
BRIDGEPOINT MEDICAL |
STINGRAY ORIENTING BALLOON CATHETER |
08/06/2010 |
K212588 |
C.R. Bard, Inc |
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter |
05/04/2022 |
K040243 |
C.R. BARD, INC. |
BARD ATLAS PTA BALLOON DILATATION CATHETER |
02/13/2004 |
K014212 |
C.R. BARD, INC. |
BARD CONQUEST PTA BALLOON DILATATION CATHETER |
01/17/2002 |
K012913 |
C.R. BARD, INC. |
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER |
09/28/2001 |
K010169 |
C.R. BARD, INC. |
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER |
02/13/2001 |
K083657 |
C.R. BARD, INC. |
CONQUEST PTA BALLOON DILATATION CATHETER |
12/24/2008 |
K203275 |
C.R. Bard, Inc. |
Recon Support Catheter |
03/01/2021 |
K131493 |
C.R. BARD, INC. |
SIDEKICK AND USHER SUPPORT CATHETERS |
08/02/2013 |
K111850 |
C.R. BARD, INC. |
VACCESS PTA DILATATION CATHETER |
07/13/2011 |
K093969 |
CARDIAC PACEMAKERS, INC. |
ACUITY BREAK-AWAY GUIDE CATHETER |
03/05/2010 |
K080154 |
CARDIAC PACEMAKERS, INC. |
ACUITY UNIVERSAL CUTTER |
03/20/2008 |
K973298 |
CARDIMA, INC. |
CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER |
06/26/1998 |
K974683 |
CARDIMA, INC. |
NAVIPORT DEFLECTABLE TIP GUIDING CATHETER |
06/22/1999 |
K183000 |
Cardiovascular Systems, Inc. |
ViperCath XC Peripheral Exchange Catheter |
12/29/2018 |
K211251 |
Cardiovascular Systems, Inc. |
ViperCath XC Peripheral Exchange Catheter |
05/26/2021 |
K211240 |
Cardiovascular Systems, Inc. |
ViperCross Support Catheters |
08/26/2021 |
K212725 |
Cardiovascular Systems, Inc. |
ViperCross Support Catheters |
09/24/2021 |
K083139 |
CARDIOVASCULAR SYSTEMS, INC. |
VIPERSPHERE PTA BALLOON CATHETER |
11/25/2008 |
K151638 |
Cathera, Inc. |
Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter |
11/13/2015 |
K180959 |
Cathera, Inc. |
Phenom 27 Catheter |
06/11/2018 |
K190475 |
CenterPoint Systems |
Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 |
06/28/2019 |
K230363 |
CenterPoint Systems LLC |
CPS Locator 3D Delivery Catheter |
03/09/2023 |
K210009 |
CenterPoint Systems LLC |
Guiding Catheter |
11/24/2021 |
K060927 |
CERES MEDICAL SYSTEMS, L.L.C. |
CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES |
10/06/2006 |
K182487 |
Cerus Endovascular, Inc. |
CerusEndo Microcatheter |
07/20/2019 |
K043580 |
CHESTNUT MEDICAL TECHNOLOGIES, INC. |
ALLIGATOR RETRIEVAL DEVICE (ARD) |
03/24/2005 |
K093977 |
CHESTNUT MEDICAL TECHNOLOGIES, INC. |
ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX |
04/22/2010 |
K112335 |
CLEAR STREAM TECHNOLOGIES, LTD. |
BANTAM CATHETER (280MM BALLOON LENGTHS) |
10/12/2011 |
K083596 |
CLEARSTREAM TECHNOLOGIES, LTD. |
REEKROSS FAMILY OR OTW PTA CATHETERS |
03/02/2009 |
K191237 |
Codman & Shurtleff, Inc. |
CERENOVUS Large Bore Catheter |
11/08/2019 |
K140080 |
Codman & Shurtleff, Inc. |
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB |
04/24/2014 |
K120229 |
Codman & Shurtleff, Inc. |
ENVOY DISTAL ACCESS GUIDING CATHETER |
02/24/2012 |
K140307 |
Codman & Shurtleff, Inc. |
ENVOY GUIDING CATHETER |
04/21/2014 |
K093184 |
Codman & Shurtleff, Inc. |
ENVOY GUIDING CATHETERS |
11/06/2009 |
K112828 |
Codman & Shurtleff, Inc. |
REVIVE INTERMEDIATE CATHETER (REVIVE IC) |
10/25/2011 |
K162563 |
CODMAN & SHURTLEFF, INC. |
YOGA Microcatheter |
01/05/2017 |
K171653 |
Codman & Shurtleff, Inc. |
YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up |
07/03/2017 |
K153729 |
CONCENTRIC MEDICAL |
8F FlowGate2 Balloon Guide Catheter |
01/27/2016 |
K102657 |
CONCENTRIC MEDICAL, INC. |
CONCENTRIC BALLOON GUIDE CATHETER |
11/17/2010 |
K112404 |
CONCENTRIC MEDICAL, INC. |
CONCENTRIC BALLOON GUIDE CATHETER |
03/15/2012 |
K010954 |
CONCENTRIC MEDICAL, INC. |
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 |
10/09/2001 |
K021899 |
CONCENTRIC MEDICAL, INC. |
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 |
07/10/2002 |
K003085 |
CONCENTRIC MEDICAL, INC. |
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 |
03/07/2001 |
K040700 |
CONCENTRIC MEDICAL, INC. |
CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 |
06/21/2004 |
K003410 |
CONCENTRIC MEDICAL, INC. |
CONCENTRIC RETRIEVER, MODEL 90030 |
05/22/2001 |
K003880 |
CONCENTRIC MEDICAL, INC. |
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) |
05/16/2001 |
K090335 |
CONCENTRIC MEDICAL, INC. |
HD GUIDE CATHETER |
05/06/2009 |
K092298 |
CONCENTRIC MEDICAL, INC. |
MODIFICATION TO MODIFIED HD GUIDE CATHETER |
11/05/2009 |
K122581 |
CONCENTRIC MEDICAL, INC. |
MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 |
11/21/2012 |
K030476 |
CONCENTRIC MEDICAL, INC. |
MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 |
03/11/2003 |
K040745 |
CONCENTRIC MEDICAL, INC. |
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 |
08/11/2004 |
K051838 |
CONCENTRIC MEDICAL, INC. |
MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 |
09/01/2005 |
K131492 |
CONCENTRIC MEDICAL, INC. |
MODIFIED FLOWGATE BALLOON GUIDE CATHETER |
10/03/2013 |
K080583 |
CONCENTRIC MEDICAL, INC. |
MODIFIED HD GUIDE CATHETER |
07/18/2008 |
K110483 |
CONCENTRIC MEDICAL, INC. |
MODIFIED HD GUIDE CATHETER |
04/04/2011 |
K133177 |
CONCENTRIC MEDICAL, INC. |
MODIFIED HD GUIDE CATHETER |
02/25/2014 |
K150970 |
COOK INCORPORATED |
Coda LP Balloon Catheter |
05/12/2015 |
K191163 |
Cook Incorporated |
Lumax Guiding Catheter |
12/12/2019 |
K090822 |
COOK, INC. |
ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER |
04/27/2009 |
K073378 |
COOK, INC. |
ADVANCE 18LP PTA DILATATION CATHETER |
12/28/2007 |
K091527 |
COOK, INC. |
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
06/12/2009 |
K131204 |
COOK, INC. |
ADVANCE CS CORONARY SINUS INFUSION CATHETER |
01/29/2014 |
K122940 |
COOK, INC. |
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 |
03/19/2013 |
K052036 |
COOK, INC. |
ATB ADVANCE PTA DILATATION CATHETER |
08/25/2005 |
K063252 |
COOK, INC. |
ATB ADVANCED PTA DILATATION CATHETER |
11/14/2006 |
K033875 |
COOK, INC. |
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
04/02/2004 |
K022552 |
COOK, INC. |
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
09/27/2002 |
K031766 |
COOK, INC. |
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
06/26/2003 |
K122917 |
COOK, INC. |
CODA BALLOON CATHETER |
06/28/2013 |
K032869 |
COOK, INC. |
COOK CODA BALLOON CATHETER |
11/19/2003 |
K990726 |
COOK, INC. |
ENVY GUIDING CATHETER |
04/02/1999 |
K101877 |
COOK, INC. |
OCCLUSION BALLOON CATHETER MODEL OBC |
08/06/2010 |
K032931 |
COOK, INC. |
PTA BALLOON CATHETER |
10/22/2003 |
K982770 |
CORDIS CORP. |
6F ENVOY GUIDING CATHETER |
08/18/1998 |
K962362 |
CORDIS CORP. |
CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS |
08/08/1996 |
K001136 |
CORDIS CORP. |
CORDIS INTRODUCER GUIDE |
04/28/2000 |
K003920 |
CORDIS CORP. |
CORDIS M3 PTA DILATATION CATHETER |
06/15/2001 |
K000715 |
CORDIS CORP. |
ENVOY AND VISTA BRITE TIP |
03/31/2000 |
K982632 |
CORDIS CORP. |
ENVOY AND VISTA BRITE TIP |
08/18/1998 |
K021593 |
CORDIS CORP. |
MODIFICATION TO ENVOY AND VISTA BRITE TIP |
06/13/2002 |
K962830 |
CORDIS CORP. |
VISTA BRITE TIP CATHETERS |
10/17/1996 |
K963962 |
CORDIS CORP. |
VISTA BRITE TIP CATHETERS |
05/07/1997 |
K965211 |
CORDIS CORP. |
VISTA BRITE TIP CATHETERS |
03/11/1997 |
K971572 |
CORDIS CORP. |
VISTA BRITE TIP CATHETERS |
07/14/1997 |
K992673 |
CORDIS CORP. |
VISTA BRITE TIP CATHETERS |
10/12/1999 |
K972978 |
CORDIS CORP. |
VISTA BRITE TIP GUIDING CATHETERS |
10/21/1997 |
K131225 |
CORDIS CORP., A JOHNSON & JOHNSON CO. |
ADROIT GUIDING CATHETER |
05/29/2013 |
K143412 |
CORDIS CORPORATION |
ADROIT Guiding Catheter |
01/14/2015 |
K032737 |
CORDIS EUROPA N.V. |
CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA |
10/02/2003 |
K965247 |
CORDIS NEUROVASCULAR, INC. |
ENVOY GUIDING CATHETER |
07/23/1997 |
K013581 |
CORDIS, A JOHNSON & JOHNSON CO. |
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER |
11/28/2001 |
K171819 |
Creganna Medical also doing business as Ceganna Tactx Medica |
Attain Assist CS Access Catheter |
01/04/2018 |
K162253 |
CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL |
Trapper Exchange Device |
01/06/2017 |
K213466 |
Cruzar Medsystems Inc |
Houdini Cross Support Catheter |
10/20/2022 |
K151896 |
Cruzar Medsystems, Inc. |
Houdini Catheter |
12/07/2015 |
K022061 |
CRYO VASCULAR SYSTEMS INC. |
CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER |
09/20/2002 |
K023463 |
CRYOVASCULAR SYSTEMS, INC. |
CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT |
02/19/2003 |
K042541 |
CRYOVASCULAR SYSTEMS, INC. |
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM |
10/12/2004 |
K042230 |
CRYOVASCULAR SYSTEMS, INC. |
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM |
11/05/2004 |
K033622 |
CRYOVASCULAR SYSTEMS, INC. |
POLARCATH PERIPHERAL DILATATION SYSTEM |
02/10/2004 |
K180797 |
Curatia Medical Co. |
Xcess Guiding Catheter |
12/14/2018 |
K141354 |
CURATIVE MEDICAL INC. |
NAVAJO PTA BALLOON DILATATION CATHETER |
01/30/2015 |
K030630 |
EDWARDS LIFESCIENCES, LLC. |
EDWARDS DIRECTIONAL CATHETER |
09/03/2003 |
K032587 |
EDWARDS LIFESCIENCES, LLC. |
EDWARDS PERIPHERAL DILATATION CATHETER |
10/02/2003 |
K052149 |
EDWARDS LIFESCIENCES, LLC. |
EDWARDS PERIPHERAL DILATION CATHETER |
09/02/2005 |
K092174 |
ENDOCROSS, LTD. |
ENABLER-P CATHETER SYSTEM, MODEL 3000 |
12/30/2009 |
K083833 |
ENDOCROSS, LTD. |
ENABLER-P CATHETER, 1000 PART NUMBER:1160 |
05/22/2009 |
K082339 |
ENDOCROSS, LTD. |
ENABLER-P SUPPORT CATHETER |
11/20/2008 |
K991601 |
ENDOLOGIX, INC. |
DUAL LUMEN CATHETER, MODEL DL-35-90 |
10/28/1999 |
K080360 |
ENDOLOGIX, INC. |
ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER |
04/08/2008 |
K043489 |
ENPATH MEDICAL INCORPORATED |
ENPATH DEFLECTABLE CATHETER |
05/19/2005 |
K061119 |
ENPATH MEDICAL, INC. |
ENPATH MEDICAL STEERABLE SHEATH |
05/18/2006 |
K092299 |
EV3 INC |
TRAILBLAZER SUPPORT CATHETER |
08/07/2009 |
K082579 |
EV3 INC. |
EVERCROSS .035 OTW PTA DILATATION CATHETER |
11/20/2008 |
K090849 |
EV3 INC. |
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 |
05/01/2009 |
K082854 |
EV3 INC. |
NANOCORSS .014 OTW PTA DILATATION CATHETER |
12/04/2008 |
K062868 |
FLOWCARDIA INC |
THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 |
01/19/2007 |
K080849 |
FLOWCARDIA, INC. |
MICROSHEATH LP AND LP-AT |
07/25/2008 |
K073289 |
FLOWCARDIA, INC. |
MICROSHEATH XL CATHETERS |
01/11/2008 |
K091254 |
FLOWCARDIA, INC. |
THE CROSSER 14 OTW CATHETER, MODEL CRU014 |
05/29/2009 |
K051580 |
FLOWCARDIA, INC. |
VP SHEATH |
10/31/2005 |
K120781 |
FUJI SYSTEMS CORP. |
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH |
08/09/2012 |
K003495 |
GUIDANT CARDIAC AND VASCULAR SURGERY |
ANCURE LLIAC BALLOON CATHETER |
02/07/2001 |
K001694 |
GUIDANT CARDIAC AND VASCULAR SURGERY |
GUIDANT RETRIEVER DEVICE |
05/15/2001 |
K000598 |
GUIDANT CORP. |
5F GUIDING CATHETER |
03/24/2000 |
K972484 |
GUIDANT CORP. |
ACS VIKING GUIDING CATHETER |
09/26/1997 |
K020161 |
GUIDANT CORP. |
AGILTRAC .018 PERIPHERAL DILATATION CATHETER |
02/22/2002 |
K022738 |
GUIDANT CORP. |
AGILTRAC .035 PERIPHERAL DILATATION CATHETER |
09/13/2002 |
K023320 |
GUIDANT CORP. |
AGILTRAC .035 PERIPHERAL DILATATION CATHETER |
12/10/2002 |
K010831 |
GUIDANT CORP. |
AVIATOR PERIPHERAL DILATATION CATHETER |
06/13/2001 |
K021284 |
GUIDANT CORP. |
EASYTRAK GUIDING CATHETER |
05/02/2002 |
K013638 |
GUIDANT CORP. |
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER |
12/04/2001 |
K031459 |
GUIDANT CORP. |
RAPIDO CUT-AWAY CUTTER |
07/23/2003 |
K021455 |
GUIDANT CORP. |
RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, |
08/02/2002 |
K012050 |
GUIDANT CORP. |
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER |
09/06/2001 |
K001435 |
GUIDANT CORP. |
VIKING OPTIMA GUIDING CATHETER |
06/02/2000 |
K012002 |
GUIDANT CORP. |
VIKING OPTIMA GUIDING CATHETER |
07/26/2001 |
K031505 |
GUIDANT CORPORATION |
RAPIDO CUT-AWAY GUIDING CATHETER |
06/25/2003 |
K100135 |
GUIDED DELIVERY SYSTEMS |
GDS-DC12 |
04/16/2010 |
K201726 |
Haolang Medical USA Corporation |
Arterial Catheter |
07/07/2021 |
K160448 |
HEALTH LINE INTERNATIONAL CORPORATION |
ARTLINE |
07/12/2016 |
K170664 |
Heraeus Medical Components, LLC |
Odyssey Micro Catheter |
11/09/2017 |
K222023 |
Hexacath |
RayFlow |
04/06/2023 |
K210110 |
IMDS Operations B.V. |
Guidion |
03/31/2021 |
K223728 |
IMDS Operations B.V. |
Micro Rx |
07/13/2023 |
K121077 |
IMDS OPERATIONS B.V. |
NHANCER |
12/21/2012 |
K200324 |
IMDS Operations B.V. |
NHancer Rx |
08/06/2020 |
K210431 |
IMDS Operations B.V. |
ReCross |
07/15/2021 |
K191229 |
IMDS Operations B.V. |
TrapIt |
01/21/2020 |
K180169 |
Imperative Care Inc. |
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, |
08/08/2018 |
K221846 |
Inari Medical |
Artix Ballon Guiding Sheath |
07/11/2022 |
K220331 |
InNeuroCo Inc. |
091 Balloon Guide Catheter |
07/29/2022 |
K171672 |
InNeuroCo, Inc |
065 Zenith, 074 Zenith |
10/19/2017 |
K172468 |
InNeuroCo, Inc |
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm |
12/06/2017 |
K161262 |
INNEUROCO, INC |
Super Distal Access (SDA) |
09/19/2016 |
K173709 |
InNeuroCo, Inc |
Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm |
01/26/2018 |
K001992 |
INTRALUMINAL THERAPEUTICS, INC. |
ILT 0.014 CATHETER, MODEL C114NL2 |
09/25/2000 |
K010531 |
INTRALUMINAL THERAPEUTICS, INC. |
ILT DEFLECTING CATHETER, MODEL C114ND1 |
04/18/2001 |
K031417 |
INTRALUMINAL THERAPEUTICS, INC. |
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 |
07/11/2003 |
K032784 |
INTRALUMINAL THERAPEUTICS, INC. |
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 |
11/18/2003 |
K012169 |
INTRALUMINAL THERAPEUTICS, INC. |
ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 |
08/30/2001 |
K030984 |
INTRALUMINAL THERAPEUTICS, INC. |
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT |
04/24/2003 |
K031692 |
INTRALUMINAL THERAPEUTICS, INC. |
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 |
08/22/2003 |
K040481 |
INTRALUMINAL THERAPEUTICS, INC. |
SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 |
03/18/2004 |
K992622 |
INTRATHERAPEUTICS, INC. |
INTRAMAX ITI GUIDE CATHETER |
09/29/1999 |
K981191 |
INTRATHERAPEUTICS, INC. |
ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 |
04/07/1999 |
K062809 |
INVATEC INNOVATIVE TECHNOLOGIES |
ADMIRAL XTREME PTA CATHETER |
10/18/2006 |
K042538 |
INVATEC INNOVATIVE TECHNOLOGIES |
SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX |
11/08/2004 |
K042537 |
INVATEC INNOVATIVE TECHNOLOGIES |
SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX |
11/08/2004 |
K083919 |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
03/13/2009 |
K042624 |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
01/10/2005 |
K050073 |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
02/11/2005 |
K052791 |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
11/04/2005 |
K010838 |
JOMED AG |
FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 |
06/21/2001 |
K021088 |
JOMED CATHETER, INC. |
JOGUIDE CARDIOVASCULAR GUIDING C ATHETER |
05/02/2002 |
K150865 |
Kaneka Corporation |
Metacross RX PTA Balloon Dilitation Catheter |
08/03/2015 |
K041151 |
KERBEROS PROXIMAL SOLUTIONS, INC. |
KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES |
07/22/2004 |
K102439 |
LAZARUS EFFECT, INC |
FUNNEL GUIDE CATHETER MODEL G1020608 |
01/12/2012 |
K110891 |
LEMAITRE VASCULAR INC. |
THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
09/13/2011 |
K121839 |
LEMAITRE VASCULAR INC. |
UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
08/08/2012 |
K081878 |
LEMAITRE VASCULAR, INC. |
LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM |
01/27/2009 |
K133026 |
LEMAITRE VASCULAR, INC. |
UNBALLOON NON-OCCLUSION MODELING CATHETER |
12/31/2013 |
K123531 |
LEMAITRE VASCULAR, INC. |
UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
12/14/2012 |
K100184 |
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
FUSTAR STEERABLE INTRODUCERS |
02/14/2011 |
K013284 |
LUMEND, INC. |
LUMEND FRONTRUNNER CTO CORONARY CATHETER |
02/11/2002 |
K011562 |
LUMEND, INC. |
LUMEND PERCUTANEOUS CATHETER |
01/16/2002 |
K023223 |
LUMEND, INC. |
MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER |
10/24/2002 |
K014117 |
LUMEND, INC. |
MODIFICATION TO OUTBACK CATHETER |
01/11/2002 |
K032298 |
LUMEND, INC. |
MODIFICATION TO OUTBACK CATHETER |
08/26/2003 |
K040771 |
LUMEND, INC. |
MODIFICATION TO OUTBACK CATHETER |
04/23/2004 |
K043534 |
LUMEND, INC. |
MODIFICATION TO OUTBACK CATHETER |
01/21/2005 |
K001577 |
LUMEND, INC. |
OUTBACK CATHETER |
01/11/2001 |
K220632 |
Marvao Medical Devices Ltd |
Boss Crossing Support Catheter |
06/02/2022 |
K970401 |
MEDI-DYNE, INC. |
MEDI-DYNE GUIDING CATHETER |
08/01/1997 |
K222873 |
Medtronic |
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system |
11/07/2022 |
K223178 |
Medtronic |
SelectSite C304 Deflectable Catheter System, C315 Delivery System |
11/08/2022 |
K050038 |
MEDTRONIC ENDOVASCULAR INNOVATIONS |
RELIANT STENT GRAFT BALLOON CATHETER |
04/13/2005 |
K192712 |
Medtronic Inc |
Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter |
08/03/2020 |
K132673 |
MEDTRONIC INC. |
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER |
10/22/2013 |
K121219 |
MEDTRONIC INC. |
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER |
09/25/2012 |
K080428 |
MEDTRONIC INC. |
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY |
12/09/2008 |
K090659 |
MEDTRONIC INC. |
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY |
03/26/2009 |
K101885 |
MEDTRONIC INC. |
MEDTRONIC C315 DELIVERY CATHETER |
09/09/2010 |
K103386 |
MEDTRONIC INC. |
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS |
02/11/2011 |
K082670 |
MEDTRONIC INC. |
MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET |
12/04/2008 |
K183493 |
Medtronic Inc. |
SelectSite C304-HIS Deflectable Catheter System |
03/15/2019 |
K183353 |
Medtronic Inc. |
Telescope Guide Extension Catheter |
03/22/2019 |
K033989 |
MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT |
MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 |
01/22/2004 |
K061480 |
MEDTRONIC IRELAND |
ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM |
08/21/2006 |
K123153 |
MEDTRONIC IRELAND |
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT |
04/09/2013 |
K053431 |
MEDTRONIC IRELAND |
ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM |
03/16/2006 |
K013517 |
MEDTRONIC VASCULAR |
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 |
04/25/2002 |
K230156 |
Medtronic Vascular |
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter |
06/30/2023 |
K030779 |
MEDTRONIC VASCULAR |
5F MEDTRONIC LAUNCHER GUIDE CATHETER |
04/24/2003 |
K062420 |
MEDTRONIC VASCULAR |
5F SHERPA ACTIVE NX GUIDE CATHETER |
09/08/2006 |
K232190 |
Medtronic Vascular |
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter |
08/22/2023 |
K083422 |
MEDTRONIC VASCULAR |
6F TAIGA GUIDING CATHETER |
02/06/2009 |
K042489 |
MEDTRONIC VASCULAR |
6F Z4 GUIDE CATHETER |
12/13/2004 |
K022764 |
MEDTRONIC VASCULAR |
7F LAUNCHER GUIDE CATHETER |
08/28/2002 |
K051846 |
MEDTRONIC VASCULAR |
7F SHERPA NX GUIDE CATHETER |
08/05/2005 |
K023402 |
MEDTRONIC VASCULAR |
8F LAUNCHER GUIDE CATHETER |
11/06/2002 |
K060418 |
MEDTRONIC VASCULAR |
8F SHERPA NX GUIDE CATHETER |
03/15/2006 |
K024032 |
MEDTRONIC VASCULAR |
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY |
12/30/2002 |
K024035 |
MEDTRONIC VASCULAR |
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY |
12/30/2002 |
K032312 |
MEDTRONIC VASCULAR |
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM |
10/21/2003 |
K012083 |
MEDTRONIC VASCULAR |
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 |
08/28/2001 |
K021589 |
MEDTRONIC VASCULAR |
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 |
05/30/2002 |
K012130 |
MEDTRONIC VASCULAR |
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM |
08/28/2001 |
K021587 |
MEDTRONIC VASCULAR |
ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A |
05/30/2002 |
K032622 |
MEDTRONIC VASCULAR |
ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS |
09/03/2003 |
K031211 |
MEDTRONIC VASCULAR |
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH |
07/17/2003 |
K042194 |
MEDTRONIC VASCULAR |
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY |
09/15/2004 |
K001969 |
MEDTRONIC VASCULAR |
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 |
08/16/2000 |
K192296 |
Medtronic Vascular |
Medtronic 6F Taiga Guiding Catheter |
09/20/2019 |
K030671 |
MEDTRONIC VASCULAR |
MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB |
07/31/2003 |
K013963 |
MEDTRONIC VASCULAR |
MODEL 9210 DELIVERY CATHETER, MODEL 9210 |
02/28/2002 |
K061416 |
MEDTRONIC VASCULAR |
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 |
10/25/2006 |
K010579 |
MEDTRONIC VASCULAR |
STENT SUPPORT GUIDE CATHETER |
11/21/2001 |
K133539 |
MEDTRONIC VASCULAR |
TOTAL ACROSS |
03/26/2014 |
K033540 |
MEDTRONIC VASCULAR |
TRANSXCHANGE SUPPORT CATHETER |
05/25/2004 |
K021256 |
MEDTRONIC VASCULAR |
Z3 GUIDE CATHETER |
05/17/2002 |
K000677 |
MEDTRONIC VASCULAR |
ZUMA GUIDE CATHETERS |
03/29/2000 |
K162384 |
Medtronic Vascular, Inc.(formerly ev3 Inc.) |
TrailBlazer Angled Support Catheter |
09/22/2016 |
K112917 |
MEDTRONIC, INC. |
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID |
10/27/2011 |
K990707 |
MEDTRONICS INTERVENTIONAL VASCULAR |
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS |
03/22/1999 |
K982883 |
MEDTRONICS INTERVENTIONAL VASCULAR |
MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER |
09/04/1998 |
K955651 |
MEDTRONICS INTERVENTIONAL VASCULAR |
MEDTRONIC SHERPA GUIDING CATHETER |
01/22/1996 |
K981198 |
MEDTRONICS INTERVENTIONAL VASCULAR |
MEDTRONIC ZUMA GUIDING CATHETER |
08/07/1998 |
K121051 |
MERIT MEDICAL SYSTEMS, INC. |
CONCIERGE GUIDING CATHETER |
06/13/2012 |
K132409 |
MERIT MEDICAL SYSTEMS, INC. |
CONCIERGE GUIDING CATHETER |
08/29/2013 |
K173548 |
Merit Medical Systems, Inc. |
Merit Pursue Microcatheter |
03/30/2018 |
K202610 |
Merit Medical Systems, Inc. |
Ventrax Delivery System |
12/14/2020 |
K231246 |
Merit Medical Systems, Inc. |
VentraxÖ Delivery System (VTR851) |
08/30/2023 |
K150107 |
MICRO THERAPEUTICS INC DBA EV3 NEUROVASCULAR |
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter |
07/29/2015 |
K161152 |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
Navien Intracranial Support Catheter |
10/12/2016 |
K180715 |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
React 68 Catheter |
07/04/2018 |
K182097 |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
React 71 Catheter |
11/14/2018 |
K211990 |
Micro Therapeutics, Inc., d/b/a ev3 Neurovascular |
Rist 071 Radial Access Guide Catheter |
07/27/2021 |
K210230 |
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular |
Phenom Catheters |
02/25/2021 |
K182602 |
Micro Vention Inc. |
SOFIA EX Intracranial Support Catheter |
05/15/2019 |
K110813 |
MICRO VENTION, INC. |
HEADWAY 27 MICROCATHETER |
08/05/2011 |
K142449 |
MICRO VENTION, INC. |
Headway 27 Microcatheter |
03/26/2015 |
K131482 |
MICRO VENTION, INC. |
SOFIA DISTAL ACCESS CATHETER |
11/22/2013 |
K172014 |
Micro Vention, Inc. |
Wedge Microcatheter |
04/05/2018 |
K171268 |
MicroTherapeutics, Inc. d/b/a ev3 Neurovascular |
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter |
05/31/2017 |
K970668 |
MICROVENA CORP. |
THE AMPLANTZ GOOSE NECK MICROSNARE |
06/10/1998 |
K182829 |
MicroVention Inc. |
Scepter Mini Occlusion Balloon Catheter |
07/10/2019 |
K193607 |
MicroVention, Inc. |
BOBBY Balloon Guide Catheter |
07/21/2020 |
K082385 |
MICROVENTION, INC. |
CHAPERON GUIDING CATHETER |
12/11/2008 |
K101542 |
MICROVENTION, INC. |
HEADWAY 17 ADVANCED MICROCATHETER |
08/06/2010 |
K083343 |
MICROVENTION, INC. |
HEADWAY 17 MICROCATHETER |
12/04/2008 |
K093160 |
MICROVENTION, INC. |
HEADWAY 21 MICROCATHETER, MODEL: MC212150S |
11/05/2009 |
K222115 |
MicroVention, Inc. |
ISAAC Neurovascular Navigation Catheter |
01/10/2023 |
K150366 |
MICROVENTION, INC. |
SOFIA 6F Catheter |
03/27/2015 |
K214024 |
MicroVention, Inc. |
SOFIA 88 Catheter |
09/12/2022 |
K142014 |
MICROVENTION, INC. |
SOFIA DISTAL ACCESS CATHETER |
10/10/2014 |
K192135 |
MicroVention, Inc. |
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) |
12/24/2019 |
K192625 |
MicroVention, Inc., A Terumo Group Company |
PG Pro Microcatheter |
11/21/2019 |
K163233 |
MIVI NEUROSCIENCE, INC |
MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter |
04/06/2017 |
K151396 |
MIVI NEUROSCIENCE, INC |
MIVI Mi-AXUS Guide Catheter |
12/09/2015 |
K192558 |
MIVI Neurovascular |
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter |
04/06/2020 |
K140557 |
MIVI, LLC |
MIVI 6F GUIDE CATHETER |
09/18/2014 |
K030715 |
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED |
SAFFRON NM GUIDING CATHETER |
04/24/2003 |
K972065 |
NEUROVENA CORP. |
AURORA |
01/27/1999 |
K102979 |
NEXGEN MEDICAL SYSTEMS, INC. |
NEXGEN PERIPHERAL GUIDE CATHETER |
01/18/2011 |
K090918 |
NFOCUS NEUROMEDICAL, INC. |
NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER |
07/30/2009 |
K193322 |
Nitiloop Ltd. |
NovaCross CTO Microcatheter |
04/02/2020 |
K172297 |
Nitiloop Ltd. |
NovaCross Microcatheter |
10/18/2017 |
K160389 |
Nitiloop Ltd. |
NovaCross Microcatheter |
03/11/2016 |
K143608 |
Nitiloop Ltd. |
NovaCross Microcatheter |
05/04/2015 |
K051343 |
NUMED, INC. |
MINI GHOST PTA CATHETER, MODEL 507 |
07/28/2005 |
K082524 |
NUMED, INC. |
MINI GHOST, MODEL: 507 |
09/26/2008 |
K030589 |
NUMED, INC. |
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS |
05/21/2003 |
K082868 |
NUMED, INC. |
MULLINS-X, MODEL 250X |
10/24/2008 |
K081680 |
NUMED, INC. |
NUCLEUS-X, MODEL 230X |
07/10/2008 |
K010880 |
NUMED, INC. |
NUMED HIGH PRESSURE PTA CATHETERS |
04/20/2001 |
K013601 |
NUMED, INC. |
NUMED MULLINS PTA CATHETER |
01/03/2002 |
K041093 |
NUMED, INC. |
NUMED MULLINS X PTA CATHETER |
05/06/2004 |
K032591 |
NUMED, INC. |
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER |
09/25/2003 |
K003643 |
NUMED, INC. |
NUMED Z-MED PTV CATHERERS |
12/27/2000 |
K022722 |
NUMED, INC. |
PTA AND PTV |
09/13/2002 |
K121859 |
NUMED, INC. |
TYSHAK NUCLEUS |
08/31/2012 |
K112629 |
ONSET MEDICAL CORPORATION |
ONSET ACCESS CATHETER SYSTEM |
10/11/2011 |
K182360 |
OrbusNeich Medical Trading Inc. |
Teleport Microcatheter |
11/09/2018 |
K132197 |
PENDRACARE INTERNATIONAL, B.V. |
CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER |
08/12/2013 |
K120585 |
PENDRACARE INTERNATIONAL, B.V. |
CONVEY GUIDING CATHETER |
08/08/2012 |
K201271 |
Penumbra, Inc. |
Benchmark BMX96 Access System |
06/11/2020 |
K142321 |
PENUMBRA, INC. |
Benchmark Intracranial Access System |
01/26/2015 |
K152840 |
PENUMBRA, INC. |
Lantern Delivery Microcatheter |
12/02/2015 |
K082290 |
PENUMBRA, INC. |
NEURON DELIVERY CATHETER 070 |
10/31/2008 |
K111380 |
PENUMBRA, INC. |
NEURON MAX SYSTEM |
07/19/2011 |
K083125 |
PENUMBRA, INC. |
NEURON SELECT CATHETER SIZE 070 |
11/21/2008 |
K070970 |
PENUMBRA, INC. |
NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F |
08/17/2007 |
K053491 |
PENUMBRA, INC. |
PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F |
04/27/2006 |
K100826 |
PENUMBRA, INC. |
PENUMBRA CATHERER 025 |
07/13/2010 |
K122772 |
PENUMBRA, INC. |
PENUMBRA DDC CATHETERS |
11/20/2012 |
K151821 |
Pryor Medical Devices, Inc |
ER-REBOA Catheter |
10/23/2015 |
K190749 |
Q'Apel |
087 Balloon Guide Catheter System |
07/15/2019 |
K181000 |
Q'Apel |
SelectFlex 072 Neurovascular Access System |
09/13/2018 |
K191664 |
Q'Apel Medical |
SelectFlex 072 Neurovascular Access System |
08/30/2019 |
K192525 |
Q'Apel Medical LLC |
087 Balloon Guide Catheter System |
10/31/2019 |
K160561 |
QXMEDICAL, LLC |
Boosting Catheter |
11/02/2016 |
K120381 |
QXMEDICAL, LLC |
Q50 PLUS STENT GRAFT BALLOON CATHETER |
02/24/2012 |
K123311 |
QXMEDICAL, LLC |
QXMEDICAL ACCESS & SUPPORT CATHETER |
01/14/2013 |
K200317 |
QXMedical, LLC |
Support Catheter |
05/14/2020 |
K042388 |
RADIANT MEDICAL |
RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE |
10/28/2004 |
K024327 |
RADIANT MEDICAL |
SETPOINT ENDOVASCULAR TEMPERATURE PROBE |
03/25/2003 |
K070502 |
RADIUS MEDICAL TECHNOLOGIES, INC. |
RADIUS SNARE |
10/04/2007 |
K130714 |
RADIUS MEDICAL, LLC |
PROGIGY SUPPORT CATHETER |
08/22/2013 |
K210188 |
Reflow Medical |
coraCross |
05/28/2021 |
K200094 |
Reflow Medical |
speX LP Support Catheter |
03/18/2020 |
K141649 |
REFLOW MEDICAL |
SPEX SUPPORT CATHETER |
11/05/2014 |
K193012 |
ReFlow Medical |
speX Support Catheter |
02/19/2020 |
K193596 |
Reflow Medical |
Wingman 14, Wingman 14C, Wingman 18, Wingman 35 |
02/20/2020 |
K151880 |
REFLOW MEDICAL |
Wingman Crossing Catheter |
08/07/2015 |
K120178 |
REFLOW MEDICAL |
WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
02/08/2012 |
K132420 |
REFLOW MEDICAL |
WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
09/19/2013 |
K141547 |
REFLOW MEDICAL |
WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
09/30/2014 |
K101479 |
REFLOW MEDICAL |
WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
08/11/2010 |
K201811 |
Reflow Medical, Inc. |
coraForce and coraFlex Support Catheters |
10/26/2020 |
K173662 |
ReFlow Medical, Inc. |
speX Support Catheter |
12/20/2017 |
K170996 |
ReFlow Medical, Inc. |
Wingman 14C Crossing Catheter |
06/09/2017 |
K190393 |
ReFlow Medical, Inc. |
Wingman 14C Crossing Catheter |
05/09/2019 |
K160848 |
ReFlow Medical, Inc. |
Wingman 18 Crossing Catheter |
07/14/2016 |
K173661 |
ReFlow Medical, Inc. |
Wingman 35 Crossing Catheter |
04/18/2018 |
K130378 |
RESPICARDIA |
RESPIGUIDE DELIVERY SYSTEM |
10/17/2013 |
K112262 |
REVERSE MEDICAL CORPORATION |
REFLEX BALLON GUIDE CATHETER |
11/02/2011 |
K122684 |
REVERSE MEDICAL CORPORATION |
REVERSE MEDICAL MICROCATHETER |
12/07/2012 |
K130858 |
REVERSE MEDICAL CORPORATION |
REVERSE MEDICAL MICROCATHETER |
10/11/2013 |
K110055 |
REVERSE MEDICAL CORPORATION |
REVERSE MEDICAL REFLEX GUIDE CATHETER |
04/05/2011 |
K102418 |
REVERSE MEDICAL CORPORATION |
REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM |
04/15/2011 |
K191551 |
RIST Neurovascular, Inc. |
RIST Cath Radial Access Long Sheath |
12/23/2019 |
K182512 |
Route 92 Medical Inc. |
Route 92 Medical Delivery Catheter |
12/10/2018 |
K190431 |
Route 92 Medical Inc. |
Route 92 Medical Delivery Catheter |
03/21/2019 |
K191717 |
Route 92 Medical Inc. |
Route 92 Medical Sheath System |
01/13/2020 |
K180201 |
Route 92 Medical, Inc. |
Route 92 Medical Access System |
05/23/2018 |
K160681 |
ROXWOOD MEDICAL, INC |
CenterCross Ultra Catheter |
06/17/2016 |
K140910 |
ROXWOOD MEDICAL, INC. |
CENTERCROSS CATHETER |
11/19/2014 |
K152456 |
ROXWOOD MEDICAL, INC. |
CenterCross Ultra Catheter |
01/26/2016 |
K170403 |
Roxwood Medical, Inc. |
CenterCross Ultra LV Catheter |
03/07/2017 |
K143744 |
ROXWOOD MEDICAL, INC. |
MicroCross Catheter |
04/14/2015 |
K151082 |
ROXWOOD MEDICAL, INC. |
MicroCross Catheter |
06/07/2015 |
K152957 |
ROXWOOD MEDICAL, INC. |
MultiCross Catheter |
03/04/2016 |
K121763 |
ROXWOOD MEDICAL, INC. |
MULTICROSS SUPPORT CATHETER |
11/27/2012 |
K210601 |
Scientia Vascular LLC |
Plato 17 Microcatheter |
04/28/2021 |
K961280 |
SCIMED LIFE SYSTEMS, INC. |
SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F |
05/15/1996 |
K974684 |
SCIMED LIFE SYSTEMS, INC. |
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER |
02/19/1998 |
K970823 |
SCIMED LIFE SYSTEMS, INC. |
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER |
06/03/1997 |
K953265 |
SCIMED LIFE SYSTEMS, INC. |
SCIMED ANGIOGRAPHIC KITS |
01/16/1996 |
K220691 |
Seigla Medical, Inc. |
LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension |
05/05/2022 |
K070126 |
SENTREHEART INC. |
OCCLUSION BALLOON CATHETER |
02/08/2008 |
K150894 |
SEQUENT MEDICAL, INC |
VIA 21 Microcatheter |
08/28/2015 |
K132652 |
SEQUENT MEDICAL, INC |
VIA MICROCATHETER, VIA PLUS MICROCATHETER |
12/20/2013 |
K162565 |
SEQUENT MEDICAL, INC. |
VIA 17 Microcatheter |
02/18/2017 |
K201706 |
Shanghai Kindly Medical Instruments Co., Ltd. |
KDL Micro catheter |
07/22/2021 |
K143459 |
SILK ROAD MEDICAL, INC |
Silk Road Acccess Catheter |
04/01/2015 |
K130649 |
SILK ROAD MEDICAL, INC |
SILK ROAD ACCESS CATHETER |
11/01/2013 |
K220716 |
Spartan Micro, Inc. |
Spartan SC 069 |
05/05/2022 |
K112032 |
SPECTRANETICS CORP. |
8FR TURBO - TANDEM SYSTEM |
10/17/2011 |
K090913 |
SPECTRANETICS CORP. |
CROSS-PILOT TURBO ELITE SUPPORT CATHETER |
05/04/2009 |
K991059 |
SPECTRANETICS CORP. |
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 |
11/16/1999 |
K022138 |
SPECTRANETICS CORP. |
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 |
09/23/2002 |
K082559 |
SPECTRANETICS CORP. |
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER |
12/11/2008 |
K033678 |
SPECTRANETICS CORP. |
SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 |
02/23/2004 |
K092396 |
SPECTRANETICS CORP. |
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS |
09/04/2009 |
K082561 |
SPECTRANETICS CORP. |
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS |
12/10/2008 |
K072750 |
SPECTRANETICS CORP. |
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 |
12/04/2007 |
K091299 |
SPECTRANETICS CORP. |
SPECTRANETICS TURBO-TANDEM SYSTEM |
07/01/2009 |
K150201 |
SPECTRANETICS, INC. |
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter |
02/27/2015 |
K131063 |
ST. JUDE MEDICAL |
AMPLATZER TORQ VUE LP DELIVERY SYSTEM |
08/15/2013 |
K053217 |
ST. JUDE MEDICAL |
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 |
03/08/2006 |
K142235 |
St. Jude Medical |
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter |
12/18/2014 |
K082932 |
ST. JUDE MEDICAL |
CPS AIM SL SLITTABLE INNER CATHETER |
12/12/2008 |
K130252 |
ST. JUDE MEDICAL |
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER |
03/20/2013 |
K142239 |
St. Jude Medical |
CPS Direct MediGuide Enabled outer catheter |
12/18/2014 |
K061710 |
ST. JUDE MEDICAL |
CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS |
07/14/2006 |
K053277 |
ST. JUDE MEDICAL |
CPS DIRECT SL OUTER CATHETER |
02/24/2006 |
K130257 |
ST. JUDE MEDICAL |
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER |
03/20/2013 |
K063638 |
ST. JUDE MEDICAL |
MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 |
05/11/2007 |
K061843 |
ST. JUDE MEDICAL |
VENTURE WIRE CONTROL CATHETER, MODEL WCC |
08/01/2006 |
K090613 |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 |
07/01/2009 |
K120296 |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER |
05/11/2012 |
K103250 |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
CPS DIRECT SL II SLITTABLE OUTER CATHETER |
01/19/2011 |
K092075 |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 |
08/07/2009 |
K073700 |
ST. JUDE MEDICAL, INC. |
6F PROXIS SYSTEM |
10/02/2008 |
K131592 |
ST. JUDE MEDICAL, INC. |
ENLIGHTN RENAL GUIDE CATHETER |
01/31/2014 |
K042850 |
STEREOTAXIS, INC. |
CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) |
08/09/2006 |
K021802 |
STEREOTAXIS, INC. |
STEREOTAXIS CATHETER ADVANCER SYSTEM |
04/08/2003 |
K151667 |
Stryker |
AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm |
11/13/2015 |
K183463 |
Stryker |
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm |
03/13/2019 |
K123452 |
Stryker |
TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM |
01/03/2013 |
K193034 |
Stryker Neurovascular |
AXS Infinity LS Plus Long Sheath |
11/29/2019 |
K163259 |
STRYKER NEUROVASCULAR |
AXS Offset Delivery Assist Catheter |
07/28/2017 |
K190833 |
Stryker Neurovascular |
AXS Vecta Aspiration Catheter |
12/15/2019 |
K142565 |
Stryker Neurovascular |
Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter |
11/14/2014 |
K113778 |
STRYKER NEUROVASCULAR |
EXCELSIOR XT-27 MICROCATHETER |
04/20/2012 |
K132542 |
STRYKER NEUROVASCULAR |
TRANSGATE GUIDE CATHETER |
11/15/2013 |
K162359 |
Surefire Medical, Inc. |
Surefire Guiding Catheter |
09/21/2016 |
K140034 |
SUREFIRE MEDICAL, INC. |
SUREFIRE GUIDING CATHETER |
02/26/2014 |
K221886 |
Surmodics Inc. |
Sublime Microcatheter |
10/14/2022 |
K173560 |
Surmodics, Inc. |
Microcatheter |
01/12/2018 |
K232647 |
Surmodics. Inc. |
Microcatheter |
09/29/2023 |
K173799 |
Terumo Corporation |
NaviCross 0.018 |
03/29/2018 |
K111556 |
TERUMO MEDICAL CORP. |
GLIDECROSS SUPPORT CATHETER |
07/29/2011 |
K981359 |
TERUMO MEDICAL CORP. |
GT LEGGIERO |
01/27/1999 |
K110540 |
TERUMO MEDICAL CORP. |
TERUMO SUPPORT CATHETER |
05/13/2011 |
K231044 |
Terumo Medical Corporation |
R2P Navicross |
07/27/2023 |
K153703 |
Texas Medical Technologies, Inc. |
Guiding Catheter |
05/12/2016 |
K170914 |
Texas Medical Technologies, Inc. |
TXM Support Catheter |
11/21/2017 |
K130850 |
THERMOPEUTIX INC. |
PRIMI AND SECONDI SUPPORT CATHETERS |
06/25/2013 |
K132701 |
THERMOPEUTIX INC. |
PRIMI SUPPORT CATHETER |
09/26/2013 |
K101015 |
THOMAS MEDICAL PRODUCTS, INC. |
GUIDE CATHETERS AND ACCESSORIES |
09/23/2010 |
K152202 |
TNI Manufacturing, Inc. |
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm |
12/14/2015 |
K152876 |
TNI Manufacturing, Inc. |
LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM |
01/08/2016 |
K183305 |
Tractus Vascular LLC |
Crossing Support Catheter |
08/05/2019 |
K180889 |
Tractus Vascular LLC |
Tractus Crossing Support Catheter |
12/07/2018 |
K193420 |
Transit Scientific |
XO Cross Support Catheter |
05/06/2020 |
K214107 |
Transit Scientific, LLC |
XO CROSS CORONARY Support Catheter |
04/11/2022 |
K210322 |
Transit Scientific, LLC |
XO Cross Support Catheter |
10/21/2021 |
K214106 |
Traverse Vascular, Inc. |
QuikPass Catheter |
01/28/2022 |
K094019 |
TRIREME MEDICAL INC |
GLIDER PTA BALLOON CATHETER |
02/12/2010 |
K111738 |
TRIREME MEDICAL, INC. |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) |
12/14/2011 |
K112281 |
TRIREME MEDICAL, INC. |
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX |
08/17/2011 |
K103534 |
TRIREME MEDICAL, INC. |
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE |
01/05/2011 |
K120964 |
UPSTREAM PERIPHERAL TECHNOLOGIES |
UPSTREAM GR CATHETER |
05/25/2012 |
K112886 |
UPSTREAM PERIPHERAL TECHNOLOGIES |
UPSTREAM SUPPORT CATHETER |
02/23/2012 |
K182937 |
Upstream Peripheral Technologies, Ltd. |
Upstream GoBack Crossing Catheter |
05/23/2019 |
K980278 |
URESIL CORP. |
URESIL VASCU-FLO INFUSION CATHETER |
11/20/1998 |
K072156 |
USCI IRELAND |
OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER |
11/09/2007 |
K082646 |
USCI IRELAND |
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER |
11/03/2008 |
K052004 |
VASCON LLC |
VASCON NEUROPATH GUIDING CATHETER |
01/19/2006 |
K033633 |
VASCON LLC |
VASCON POLARIS GUIDING CATHETER |
02/18/2004 |
K043387 |
VASCON LLC |
VASCON POLARIS GUIDING CATHETER |
02/16/2005 |
K011464 |
VASCULAR INTERVENTION |
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN |
06/13/2001 |
K151981 |
VASCULAR SOLUTION, INC. |
Turnpike catheter |
08/13/2015 |
K220647 |
Vascular Solutions LLC |
GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) |
08/18/2022 |
K210647 |
Vascular Solutions LLC |
SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter |
04/30/2021 |
K212211 |
Vascular Solutions LLC |
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter |
02/09/2022 |
K191560 |
Vascular Solutions LLC |
Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter |
08/09/2019 |
K193119 |
Vascular Solutions LLC |
Twin-Pass Dual Access Catheter |
06/29/2020 |
K111334 |
VASCULAR SOLUTIONS, INC. |
BENELLI ACCESS DEVICE |
08/01/2011 |
K070372 |
VASCULAR SOLUTIONS, INC. |
GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 |
06/01/2007 |
K091345 |
VASCULAR SOLUTIONS, INC. |
GOPHER GOLD CATHETER, MODEL 5620 |
06/12/2009 |
K091750 |
VASCULAR SOLUTIONS, INC. |
GUIDELINER CATHETER, MODELS 5571, 5572, 5573 |
11/04/2009 |
K112082 |
VASCULAR SOLUTIONS, INC. |
GUIDELINER V2 CATHETER |
12/01/2011 |
K172090 |
Vascular Solutions, Inc. |
GuideLiner V3 Catheter |
10/20/2017 |
K133501 |
VASCULAR SOLUTIONS, INC. |
LEADLINER CS LEAD DELIVERY SYSTEM |
02/25/2014 |
K112100 |
VASCULAR SOLUTIONS, INC. |
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER |
03/20/2012 |
K082337 |
VASCULAR SOLUTIONS, INC. |
MINNIE SUPPORT CATHETER |
01/15/2009 |
K090977 |
VASCULAR SOLUTIONS, INC. |
PIGGYBACK WIRE CONVERTER |
06/18/2009 |
K101659 |
VASCULAR SOLUTIONS, INC. |
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 |
12/16/2010 |
K120707 |
VASCULAR SOLUTIONS, INC. |
SWITCH-IT CATHETER |
05/15/2012 |
K161901 |
Vascular Solutions, Inc. |
TrapLiner catheter |
02/03/2017 |
K180088 |
Vascular Solutions, Inc. |
TrapLiner catheter |
04/04/2018 |
K142065 |
VASCULAR SOLUTIONS, INC. |
TURNPIKE CATHETER |
11/25/2014 |
K072618 |
VASCULAR SOLUTIONS, INC. |
TWIN-PASS OTW CATHETER, MODEL 5201 |
11/21/2007 |
K162467 |
VASCULAR SOLUTIONS, INC. |
Twin-Pass Torque |
02/01/2017 |
K052258 |
VASCULAR SOLUTIONS, INC. |
VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER |
12/13/2005 |
K052257 |
VASCULAR SOLUTIONS, INC. |
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER |
11/23/2005 |
K060327 |
VASCULAR SOLUTIONS, INC. |
VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER |
04/12/2006 |
K171335 |
Vascular Solutions, Inc. |
Venture 038 catheter |
06/07/2017 |
K182570 |
Vascular Solutions, LLC |
Venture 0.014 Catheter |
03/13/2019 |
K023548 |
VELOCIMED |
PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 |
08/04/2003 |
K042117 |
VELOCIMED INC. |
PROXIS SYSTEM, MODEL EPS 101 |
01/07/2005 |
K040922 |
VELOCIMED INC. |
VENTURE WIRE CONTROL CATHETER |
08/18/2004 |
K042910 |
VELOCIMED INC. |
VENTURE WIRE CONTROL CATHETER, MODEL WCC |
11/22/2004 |
K091624 |
VIA BIOMEDICAL, INC. |
STENT GRAFT BALLOON CATHETER |
10/15/2009 |
K122826 |
VOLCANO CORPORATION |
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM |
04/24/2013 |
K112035 |
VOLCANO CORPORATION |
VALET MICRO CATHETER |
01/05/2012 |
K132659 |
VOLCANO CORPORATION |
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM |
09/27/2013 |
K081799 |
W. L. GORE & ASSOCIATES, INC. |
GORE TRI-LOBE BALLOON CATHETER |
10/03/2008 |
K033670 |
W. L. GORE & ASSOCIATES, INC. |
GORE TRI-LOBE BALLOON CATHETER |
05/05/2004 |
K180919 |
W.L. Gore and Associates Inc. |
GORE Tri-Lumen Catheter |
10/05/2018 |
K222603 |
Wallaby Medical Inc |
6F Wallaby Long Sheath |
03/02/2023 |
K170041 |
XABLECATH, INC. |
XableCath Support Catheter |
09/07/2017 |
K180986 |
XableCath, Inc. |
XableCath Support Catheter Product Family |
05/15/2018 |
K032660 |
XTRAK MEDICAL INC. |
XTRAK SUPPORT CATHETER |
10/29/2003 |