FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K024126 |
ABBOTT LABORATORIES |
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT |
01/14/2003 |
K011217 |
ABBOTT LABORATORIES |
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT |
05/16/2001 |
K230411 |
Abbott Medical |
Dragonfly OpStarÖ Imaging Catheter |
04/14/2023 |
K192019 |
Abbott Medical |
Dragonfly OpStarÖ Imaging Catheter, AptiVueÖ Software version E.5.1 |
11/08/2019 |
K192267 |
Abbott Medical |
ILUMIEN System with AptiVue Software version D.3 |
12/17/2019 |
K231293 |
Accurate Medical Therapeutics |
DrakonÖ and Sequre« Microcatheters |
06/01/2023 |
K203487 |
Accurate Medical Therapeutics Ltd |
Drakon and Sequre Microcatheters |
12/11/2020 |
K202797 |
Accurate Medical Therapeutics Ltd. |
Drakon and Sequre Microcatheters |
10/23/2020 |
K173430 |
Accurate Medical Therapeutics Ltd. |
SeQure« NF and SeQure« Microcatheters |
01/26/2018 |
K021015 |
ACIST MEDICAL SYSTEMS |
ACIST PLUS 4 ANGIOGRAPHIC CATHETER |
04/26/2002 |
K012983 |
ACIST MEDICAL SYSTEMS, INC. |
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER |
03/13/2002 |
K992631 |
ACUSON CORP. |
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER |
12/15/1999 |
K955111 |
ADAM SPENCE CORP. |
MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER |
01/31/1996 |
K964331 |
ADAM SPENCER CORP. |
ASC HIGH PRESSURE BRAIDED TUBES |
01/13/1997 |
K963092 |
ADAM SPENCER CORP. |
MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER |
01/13/1997 |
K143604 |
ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S |
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters |
06/25/2015 |
K964033 |
ANGIODYNAMICS, INC. |
3F ANGIOPTIC ANGIOGRAPHIC CATHETER |
05/06/1997 |
K032376 |
ANGIODYNAMICS, INC. |
ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER |
08/26/2003 |
K151724 |
ANGIODYNAMICS, INC. |
AngioDynamics Mariner Angiographic Catheters |
10/14/2015 |
K061733 |
ANGIODYNAMICS, INC. |
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER |
08/24/2006 |
K112452 |
ANGIODYNAMICS, INC. |
ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS |
03/30/2012 |
K001578 |
ANGIODYNAMICS, INC. |
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER |
10/13/2000 |
K003901 |
ANGIODYNAMICS, INC. |
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER |
01/17/2001 |
K173762 |
AngioDynamics, Inc. |
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters |
07/18/2018 |
K163141 |
AngioDynamics, Inc. |
NAMIC ClearaCIL Contrast Injection Lines |
01/06/2017 |
K161596 |
AngioDynamics, Inc. |
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters |
04/28/2017 |
K042685 |
ANGIOMETRX INC. |
METRICATH SYSTEM |
11/18/2004 |
K024000 |
ANGIOMETRX INC. |
METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER |
06/26/2003 |
K984627 |
ARTERIAL VASCULAR ENGINEERING, INC. |
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER |
07/27/1999 |
K051561 |
ASAHI INTECC CO., LTD. |
ASAHI ANGIOGRAPHIC CATHETER |
11/02/2005 |
K150232 |
ASHITAKA FACTORY OF TERUMO CORP. |
Radifocus Optitorque Angiographic Catheter |
10/19/2015 |
K170223 |
ASHITAKA FACTORY OF TERUMO CORPORATION |
Progreat |
07/21/2017 |
K955485 |
B. BRAUN MEDICAL, INC. |
BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS |
02/23/1996 |
K190126 |
Bend It Technologies Ltd |
Bendit2.7 Steerable Microcatheter |
08/22/2019 |
K012749 |
BIOCARDIA, INC. |
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 |
01/24/2002 |
K022004 |
BIOSENSORS INTERNATIONAL-USA |
CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1 |
03/12/2003 |
K101669 |
BIOSENSORS INTL. PTE. LTD. |
THERMODILUTION CATHETER |
07/01/2010 |
K083384 |
BIOSENSORS INTL. PTE. LTD. |
THERMODILUTION CATHETER |
01/05/2010 |
K003105 |
BIOSPHERE MEDICAL |
BIOSPHERE MEDICAL INFUSION CATHETER |
05/22/2001 |
K062126 |
BIOSPHERE MEDICAL, INC. |
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 |
08/09/2006 |
K102633 |
BIOTEQUE CORP. |
BIOTEQ ANGIOGRAPHIC CATHETER |
09/09/2011 |
K050684 |
BOSTON SCIENTIFIC CORP. |
ATLANTIS PV |
05/20/2005 |
K050577 |
BOSTON SCIENTIFIC CORP. |
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 |
03/30/2005 |
K040776 |
BOSTON SCIENTIFIC CORP. |
ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 |
04/29/2004 |
K022621 |
BOSTON SCIENTIFIC CORP. |
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER |
09/04/2002 |
K050863 |
BOSTON SCIENTIFIC CORP. |
IMAGER II ANGIOGRAPHIC CATHETER |
09/02/2005 |
K121694 |
BOSTON SCIENTIFIC CORP. |
IMAGER II ANGIOGRAPHIC CATHETER |
09/14/2012 |
K120893 |
BOSTON SCIENTIFIC CORP. |
IMAGER II ANGIOGRAPHIC CATHETERS |
03/29/2012 |
K120495 |
BOSTON SCIENTIFIC CORP. |
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER |
05/21/2012 |
K060175 |
BOSTON SCIENTIFIC CORP. |
ISIGHT IMAGING CATHETER, MODEL 38986 |
03/24/2006 |
K971607 |
BOSTON SCIENTIFIC CORP. |
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS |
07/24/1997 |
K970207 |
BOSTON SCIENTIFIC CORP. |
MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS |
07/31/1997 |
K063312 |
BOSTON SCIENTIFIC CORP. |
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 |
11/30/2006 |
K023681 |
BOSTON SCIENTIFIC CORP. |
RENEGADE STC 18 MICROCATHETER |
11/26/2002 |
K152605 |
BOSTON SCIENTIFIC CORPORATION |
Impulse Angiographic Catheter, Expo Angiographic Catheter |
10/29/2015 |
K000743 |
BOSTON SCIENTIFIC SCIMED, INC. |
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 |
09/06/2000 |
K961499 |
BOSTON SCIENTIFIC SCIMED, INC. |
LAGUNA SOFTIP DIAGNOSTIC CATHETERS |
10/17/1996 |
K000956 |
BOSTON SCIENTIFIC SCIMED, INC. |
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS |
04/21/2000 |
K992123 |
BOSTON SCIENTIFIC SCIMED, INC. |
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS |
08/23/1999 |
K982077 |
BOSTON SCIENTIFIC SCIMED, INC. |
SELECTOR DIAGNOSTIC CATHETER |
08/11/1998 |
K010707 |
BOSTON SCIENTIFIC, TARGET |
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 |
03/29/2001 |
K011664 |
BOSTON SCIENTIFIC/MEDI-TECH |
IMAGER II ANGIOGRAPHIC CATHETER |
09/07/2001 |
K020012 |
BOSTON SCIENTIFIC/MEDI-TECH |
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER |
01/29/2002 |
K980575 |
C.R. BARD, INC. |
SITESEER ANGIOGRAPHIC CATHETER |
05/15/1998 |
K971034 |
C.R. BARD, INC. |
USCI MAINSTAY GUIDING CATHETER |
05/28/1997 |
K960056 |
C.R. BARD, INC. |
USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC |
10/23/1996 |
K003020 |
CD LEYCOM BV |
CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER |
05/11/2001 |
K031599 |
CD LEYCOM BV |
CD LEYCOM PRESSURE/VOLUME CATHETERS |
12/09/2003 |
K071196 |
COEUR, INC. |
DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS |
09/06/2007 |
K151126 |
Colibri Technologies Inc. |
Foresight Intracardiac Echocardiography (ICE) System |
12/18/2015 |
K162789 |
Conavi Medical Inc. |
Foresight Intracardiac Echocardiology (ICE) System |
03/28/2017 |
K003086 |
CONCENTRIC MEDICAL, INC. |
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 |
05/16/2001 |
K072796 |
CONCENTRIC MEDICAL, INC. |
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044 |
12/18/2007 |
K113260 |
CONCENTRIC MEDICAL, INC. |
MODIFIED CONCENTIRC MICROCATHETER |
03/09/2012 |
K111619 |
CONCENTRIC MEDICAL, INC. |
MODIFIED CONCENTRIC MICROCATHETER |
07/06/2011 |
K131437 |
CONCENTRIC MEDICAL, INC. |
MODIFIED CONCENTRIC MICROCATHETER |
10/11/2013 |
K091961 |
CONCENTRIC MEDICAL, INC. |
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 |
07/30/2009 |
K180792 |
Cook Incorporated |
Arterial Pressure Monitoring Set/Tray |
11/30/2018 |
K180846 |
Cook Incorporated |
Arterial Pressure Monitoring Set/Tray |
12/19/2018 |
K173289 |
Cook Incorporated |
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter |
11/15/2017 |
K172635 |
Cook Incorporated |
High-Flo Silver Polyethylene Catheter |
04/03/2018 |
K180286 |
Cook Incorporated |
Polyethylene Catheter |
10/26/2018 |
K181722 |
Cook Incorporated |
Polyethylene Catheter |
03/22/2019 |
K171264 |
Cook Incorporated |
Royal Flush Catheter |
01/25/2018 |
K180054 |
Cook Incorporated |
Royal Flush Plus High-Flow Catheter |
10/05/2018 |
K161822 |
Cook Incorporated |
Torcon NB Advantage Catheters |
10/27/2016 |
K162448 |
Cook Incorporated |
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter |
05/26/2017 |
K133130 |
COOK, INC. |
BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER |
01/09/2015 |
K002254 |
COOK, INC. |
COOK PRESSURE MONITORING CATHETER |
03/16/2001 |
K974774 |
COOK, INC. |
ENVY GUIDING CATHETER |
10/16/1998 |
K122937 |
COOK, INC. |
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) |
12/14/2012 |
K960975 |
CORDIS CORP. |
1-4F INFINITI ANGIOGRAPHIC CATHETER |
04/02/1996 |
K962759 |
CORDIS CORP. |
4F NYLEX ANGIOGRAPHIC CATHETER |
10/10/1996 |
K971646 |
CORDIS CORP. |
4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER |
07/14/1997 |
K970854 |
CORDIS CORP. |
5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER |
09/30/1997 |
K992347 |
CORDIS CORP. |
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS |
10/08/1999 |
K991673 |
CORDIS CORP. |
CORDIS TEMPO ANGIOGRAPHY CATHETER |
05/26/1999 |
K020316 |
CORDIS CORP. |
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU |
03/20/2002 |
K973401 |
CORDIS CORP. |
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS) |
11/18/1997 |
K000579 |
CORDIS CORP. |
TEMPO AQUA ANGIOGRAPHIC CATHETER |
05/03/2000 |
K212977 |
Cordis Corporation |
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands |
02/17/2022 |
K181836 |
Cordis, a Cardinal Health Company |
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters |
08/08/2018 |
K090427 |
CURATIVE MEDICAL TECHNOLOGY, INC. |
URSA ANGIOGRAPHIC CATHETER |
01/29/2010 |
K123818 |
CURATIVE MEDICAL TECHNOLOGY, INC. |
URSA ANGIOGRAPHIC CATHETER |
03/04/2013 |
K982299 |
DAIG CORP. |
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER |
10/19/1998 |
K962805 |
DAIG CORP. |
SPYGLASS ANGIOGRAPHIC CATHETER |
10/15/1996 |
K965249 |
DAIG CORP. |
SPYGLASS ANGIOGRAPHIC CATHETER |
02/21/1997 |
K971616 |
DATA SCIENCES INTL., INC. |
BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70) |
11/04/1998 |
K023591 |
DEROYAL INDUSTRIES, INC. |
ULTRA HIGH PRESSURE INJECTOR LINES |
06/18/2003 |
K110103 |
EDWARDS LIFESCIENCES LLC |
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER |
02/11/2011 |
K014054 |
EDWARDS LIFESCIENCES, LLC. |
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL |
03/08/2002 |
K034043 |
ELCAM MEDICAL A.C.A.L. |
H-FLOW VALVE |
06/30/2004 |
K000820 |
ENDOSONICS CORP. |
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 |
06/05/2000 |
K230620 |
Gentuity, LLC |
Gentuity« HF-OCT Imaging System with Vis-Rx« Micro-Imaging Catheter |
08/08/2023 |
K970469 |
GUIDANT CARDIAC AND VASCULAR SURGERY |
EVT ANGIOSCALE ANGIOGRAPHIC CATHETER |
05/08/1997 |
K021283 |
GUIDANT CORP. |
GUIDANT BALLOON CATHETER, SEVERAL MODELS |
05/02/2002 |
K962829 |
HARMAC MEDICAL PRODUCTS, INC. |
HARMAC BALLOON ANGIOGRAPHIC CATHETER |
10/16/1997 |
K963335 |
HARMAC MEDICAL PRODUCTS, INC. |
HARMAC BALLOON WEDGE PRESSURE CATHETER |
10/16/1997 |
K063784 |
ICU MEDICAL, INC |
DYE MANAGEMENT SYSTEM |
04/16/2007 |
K052865 |
ICU MEDICAL, INC. |
HOSPIRA CATH LAB CONVENIENCE KITS |
12/22/2005 |
K052908 |
Infraredx, Inc. |
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 |
06/23/2006 |
K070011 |
IRVINE BIOMEDICAL,INC.(IBI) |
IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER |
03/20/2007 |
K003938 |
JOMED, INC. |
TRAK BACK II |
01/18/2001 |
K031485 |
KERBEROS PROXIMAL SOLUTIONS |
RINSPIRATION SYSTEM |
09/25/2003 |
K041291 |
KERBEROS PROXIMAL SOLUTIONS, INC. |
RINSPIRATION SYSTEM |
05/21/2004 |
K041123 |
KERBEROS PROXIMAL SOLUTIONS, INC. |
RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 |
08/26/2004 |
K141453 |
LIGHTLAB IMAGING, INC. |
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER |
09/19/2014 |
K141769 |
LIGHTLAB IMAGING, INC. |
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER |
08/18/2014 |
K952984 |
MAP MEDICAL EQUIPMENT, INC. |
MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F) |
01/29/1996 |
K990173 |
MAXXIM MEDICAL |
PATHFINDER II ANGIOGRAPHIC CATHETER |
12/21/1999 |
K000825 |
MEDI-DYNE, INC. |
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER |
09/21/2000 |
K002416 |
MEDICAL DEVICE TECHNOLOGIES, INC. |
GOLDEN-RULE SCALING CATHETER |
09/11/2000 |
K091780 |
MEDIGUIDE, LTD. |
GUIDED MEASUREMENT CATHETER (GMC) |
10/16/2009 |
K965112 |
MEDLINE INDUSTRIES, INC. |
MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS |
10/10/1997 |
K160660 |
Medline Industries, Inc. |
Medline Waste Station |
01/19/2017 |
K120008 |
MEDLINE, INDUSTRIES, INC. |
MEDLINE HIGH PRESSURE INJECTION TUBING |
08/17/2012 |
K050371 |
MEDRAD, INC. |
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER |
06/07/2005 |
K161287 |
MEDTRONIC VASCULAR |
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak |
08/19/2016 |
K980973 |
MEDTRONICS INTERVENTIONAL VASCULAR |
MEDTRONIC ANGIOGRAPHIC CATHETER |
12/10/1998 |
K191608 |
Merit Medical Systems, Inc. |
Impress Angiographic Catheter |
07/16/2019 |
K093004 |
MERIT MEDICAL SYSTEMS, INC. |
IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING |
02/12/2010 |
K053171 |
MERIT MEDICAL SYSTEMS, INC. |
MERIT IMPRESS DIAGNOSTIC CATHETER |
01/19/2006 |
K110643 |
MERIT MEDICAL SYSTEMS, INC. |
MERIT MARQUIS FLOW SWITCH |
07/01/2011 |
K000659 |
MERIT MEDICAL SYSTEMS, INC. |
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT |
03/29/2000 |
K120917 |
MICROVENTION, INC. |
HEADWAY DUO MICROCATHETER |
08/02/2012 |
K032624 |
MICRUS CORP. |
MICRUS MICROCATHETER |
09/10/2003 |
K070456 |
MICRUS ENDOVASCULAR CORPORATION |
MICRUS COURIER ENZO MICROCATHETER 0.017 |
05/24/2007 |
K072526 |
MICRUS ENDOVASCULAR CORPORATION |
MICRUS COURIER ENZO MICROCATHETER 0.0190 |
10/05/2007 |
K060116 |
MICRUS ENDOVASCULAR CORPORATION |
MICRUS COURIER MICROCATHETERS |
05/12/2006 |
K061963 |
MICRUS ENDOVASCULAR CORPORATION |
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 |
08/04/2006 |
K083922 |
MICRUS ENDOVASCULAR CORPORATION |
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 |
05/06/2009 |
K092702 |
MICRUS ENDOVASCULAR CORPORATION |
MICRUS MICROCATHETER, MODEL COURIER 270 |
11/20/2009 |
K993694 |
MILLAR INSTRUMENTS, INC. |
MIKRO-TIP ANGIOGRAPHIC CATHETER |
03/01/2000 |
K112124 |
NAVILYST MEDICAL, INC. |
MICROCATHETER |
08/19/2011 |
K113638 |
NAVILYST MEDICAL, INC. |
NMI 2.8 MICROCATHETER |
01/05/2012 |
K121954 |
NAVILYST MEDICAL, INC. |
NMI MICROCATHETER |
07/17/2012 |
K032888 |
NEICH MEDICAL (SHENZHEN) COMPANY LIMITED |
CREATION NM DIAGNOSTIC CATHETERS |
02/24/2004 |
K984258 |
NEURO VASX, INC. |
NEUROVASX SUB-MICROINFUSION CATHETER |
02/11/1999 |
K960801 |
NORTH AMERICAN INSTRUMENT CORP. |
SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) |
03/29/1996 |
K003902 |
NUMED, INC. |
MULTITRACK ANGIOGRAPHIC CATHETER |
01/11/2001 |
K960070 |
NUMED, INC. |
NUMED ATRIOSEPTOSTOMY CATHETER |
04/02/1996 |
K040830 |
NUMED, INC. |
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS |
06/18/2004 |
K003288 |
ORIGEN BIOMEDICAL, INC. |
ORIGEN DUAL LUMEN CATHETER |
06/08/2001 |
K092118 |
Oscor Inc. |
ANGIOGRAPHIC CATHETER, MODEL ANGIOS |
01/13/2010 |
K113819 |
PEDIACATH INC. |
MONGOOSE ANGIOGRAPHIC CATHETER |
07/11/2012 |
K213666 |
PFM Medical, Inc. |
NuCath Wedge Pressure Catheter |
10/06/2022 |
K221279 |
phenox Ltd |
pNOVUS 21 Microcatheter |
11/28/2022 |
K121734 |
SCIENTIA VASCULAR , LLC |
PLATO MICROCATH 27 MICROCATHETER |
07/30/2012 |
K143398 |
SCIENTIA VASCULAR , LLC |
Plato MICROCATH 27B Microcatheter |
06/26/2015 |
K170406 |
Scientia Vascular LLC |
Plato MICROCATH 27B Microcatheter |
04/18/2017 |
K992142 |
SCIMED |
SCIMED ANGIOGRAPHIC CATHETERS |
07/21/1999 |
K964859 |
SCIMED LIFE SYSTEMS, INC. |
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS |
02/10/1997 |
K974559 |
SCIMED LIFE SYSTEMS, INC. |
SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS |
02/23/1998 |
K981788 |
SCIMED LIFE SYSTEMS, INC. |
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER |
08/18/1998 |
K060010 |
SEDAT |
NAUTIFLUX |
08/04/2006 |
K201929 |
Shanghai Kindly Medical Instruments Co., Ltd. |
KDL Angiography Catheter |
05/14/2021 |
K131770 |
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD |
PRESSURE CONNECTING TUBE |
02/26/2014 |
K090276 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM |
02/19/2009 |
K020890 |
ST. JUDE MEDICAL |
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER |
04/17/2002 |
K101239 |
ST. JUDE MEDICAL |
VIEWFLEX PLUS ICE CATHETER |
06/02/2010 |
K192122 |
Stryker |
Trevo Trak 21 Microcatheter |
11/22/2019 |
K140356 |
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD |
SUMMED HIGH PRESSURE LINE |
03/20/2015 |
K113737 |
SUREFIRE MEDICAL, INC |
SUREFIRE GUIDE SHEATH |
02/23/2012 |
K110459 |
SUREFIRE MEDICAL, INC |
SUREFIRE INFUSION CATHETER SYSTEM |
06/24/2011 |
K160662 |
SUREFIRE MEDICAL, INC |
Surefire Infusion System |
03/11/2016 |
K143588 |
SUREFIRE MEDICAL, INC |
Surefire Infusion System 021 |
01/12/2015 |
K121677 |
SUREFIRE MEDICAL, INC. |
SUREFIRE HI-FLOW MICROCATHETER |
06/14/2012 |
K171355 |
Surefire Medical, Inc. |
Surefire Precision Infusion System |
05/17/2017 |
K180677 |
Surefire Medical, Inc. |
Surefire Spark Infusion System |
04/03/2018 |
K193647 |
Suzhou Hengrui Disheng Medical Co.,Ltd. |
Superpipe Angiographic Catheter |
07/29/2020 |
K964210 |
TARGET THERAPEUTICS |
RETRIEVER II |
10/31/1997 |
K960806 |
TARGET THERAPEUTICS |
TURBO TRACKER |
05/02/1996 |
K211078 |
Terumo Clinical Supply Co., Ltd. |
Progreat Lambda |
12/21/2021 |
K092372 |
TERUMO CORP. |
HEARTRAIL III GUIDING CATHETER |
09/11/2009 |
K113335 |
TERUMO Corporation |
HEARTRAIL III GUIDING CATHETER |
07/16/2012 |
K033583 |
TERUMO MEDICAL CORP. |
PROGREAT |
12/12/2003 |
K090040 |
TERUMO MEDICAL CORP. |
RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) |
02/06/2009 |
K992051 |
TERUMO MEDICAL CORP. |
RADIFOCUS OPTITORQUE |
08/10/1999 |
K082736 |
TERUMO MEDICAL CORP. |
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER |
09/24/2008 |
K142817 |
TEXAS MEDICAL TECHNOLOGIES, INC. |
IntraNovo 25 Microcatheter |
04/23/2015 |
K153125 |
Texas Medical Technologies, Inc. |
IntraNovo Microcatheter |
01/13/2016 |
K052637 |
THEROX, INC. |
THEROX INFUSION CATHETER, MODEL INCA-1 |
03/08/2006 |
K981441 |
TRINITY LABORATORIES, INC. |
HEART CATH TRAY, STERILE, DISPOSABLE |
07/10/1998 |
K221470 |
Vascular Solutions LLC |
Langston dual lumen catheter |
06/17/2022 |
K101625 |
VASCULAR SOLUTIONS, INC. |
COHEN CROSSOVER CATHETER |
07/19/2010 |
K073200 |
VASCULAR SOLUTIONS, INC. |
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582 |
02/01/2008 |
K081846 |
VASCULAR SOLUTIONS, INC. |
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951 |
01/28/2009 |
K062627 |
VASCULAR SOLUTIONS, INC. |
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900 THROUGH 7905 |
01/05/2007 |
K073585 |
VASCULAR SOLUTIONS, INC. |
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 |
04/17/2008 |
K061565 |
VASCULAR SOLUTIONS, INC. |
LANGSTON DUAL LUMEN CATHETER |
08/02/2006 |
K170544 |
Vascular Solutions, Inc. |
Langston dual lumen catheter |
11/17/2017 |
K050168 |
VASCULAR SOLUTIONS, INC. |
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER |
05/18/2005 |
K051395 |
VASCULAR SOLUTIONS, INC. |
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER |
06/24/2005 |
K062877 |
VASCULAR SOLUTIONS, INC. |
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230 |
01/18/2007 |
K041909 |
VASCULAR SOLUTIONS, INC. |
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) |
09/23/2004 |