FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K072824 |
ABBOTT LABORATORIES |
FOX SV PTA CATHETER |
10/23/2007 |
K062843 |
ABBOTT LABORATORIES |
FOX SV PTA CATHETER |
10/17/2006 |
K051519 |
ABBOTT LABORATORIES (PERCLOSE, INC.) |
FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) |
06/21/2005 |
K040954 |
ABBOTT LABORATORIES INC |
FOX PLUS PTA CATHETER |
05/11/2004 |
K151317 |
ABBOTT VASCULAR |
Armada 18 PTA Catheter |
07/06/2015 |
K111899 |
Abbott Vascular |
ARMADA 35/35LL PTA CATHETER |
10/03/2011 |
K092286 |
Abbott Vascular |
FOX SV PTA CATHETER |
08/27/2009 |
K221057 |
Abbott Vascular |
Viatrac 14 Plus Peripheral Dilatation Catheter |
05/05/2022 |
K102705 |
ABBOTT VASCULAR INC. |
ARMADA 14 PTA CATHETER |
12/07/2010 |
K080925 |
ABBOTT VASCULAR INC. |
FOX PLUS PTA CATHETER |
04/28/2008 |
K081417 |
ABBOTT VASCULAR INC. |
FOXCROSS PTA CATHETER |
06/04/2008 |
K080264 |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
MODIFICATION TO: FOX PLUS PTA CATHETER |
03/26/2008 |
K072798 |
ABBOTT VASCULAR-VASCULAR SOLUTIONS |
VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER |
01/31/2008 |
K991540 |
ANGIODYNAMICS, INC. |
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
09/29/1999 |
K051042 |
ANGIOMETRX INC. |
METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 |
08/05/2005 |
K090364 |
ANGIOSLIDE, LTD |
EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE |
03/23/2010 |
K133043 |
ANGIOSLIDE, LTD |
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
12/06/2013 |
K120164 |
ANGIOSLIDE, LTD |
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
06/08/2012 |
K120805 |
ANGIOSLIDE, LTD |
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
04/13/2012 |
K172494 |
Angioslide, Ltd. |
PROTEUS PTA Balloon Catheter with Embolic Capture Feature |
12/15/2017 |
K151153 |
ARRAVASC LIMITED |
Pirouette 018 |
08/20/2015 |
K161427 |
ArraVasc Limited |
Pirouette 035 |
07/30/2016 |
K162316 |
ArraVasc Ltd |
Pirouette 014 |
11/22/2016 |
K172033 |
ArraVasc Ltd |
Pirouette High Pressure (HP) |
08/31/2017 |
K170635 |
AV Medical Technologies Ltd |
Chameleon PTA Balloon Catheter |
03/30/2017 |
K151678 |
AV Medical Technologies Ltd |
Chameleon PTA Balloon Catheter |
09/21/2015 |
K163231 |
AV Medical Technologies Ltd |
Chameleon PTA Balloon Catheter |
01/17/2017 |
K030062 |
AVANTEC VASCULAR CORP. |
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 |
04/03/2003 |
K120971 |
BARD PERIPHERAL VASCULAR, INC. |
ATLAS PTA BALLOON DILATATION CATHETER |
04/19/2012 |
K120660 |
BARD PERIPHERAL VASCULAR, INC. |
CONQUEST 40 PTA DILATATION CATHETER |
03/15/2012 |
K120722 |
BARD PERIPHERAL VASCULAR, INC. |
RIVAL PTA DILATATION CATHETER |
04/19/2012 |
K192318 |
Bard Peripheral Vascular, Inc. |
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters |
10/03/2019 |
K142261 |
Bard Peripheral Vascular, Inc. |
Ultraverse 035 PTA Balloon Dilatation Catheter |
09/24/2014 |
K131199 |
BARD PERIPHERAL VASCULAR, INC. |
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER |
05/30/2013 |
K052757 |
BIOTRONIK AG |
PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER |
10/28/2005 |
K214038 |
BIOTRONIK, Inc. |
Oscar Peripheral Multifunctional Catheter system |
07/06/2022 |
K072765 |
BIOTRONIK, INC. |
PASSEO 18 |
12/12/2007 |
K152240 |
BIOTRONIK, INC. |
Passeo-14 Peripheral Dilatation Catheter |
10/08/2015 |
K151744 |
BIOTRONIK, INC. |
Passeo-18 Peripheral Dilation Catheter |
10/08/2015 |
K130161 |
BIOTRONIK, INC. |
PASSEO-35 |
04/23/2013 |
K142379 |
BIOTRONIK, INC. |
Passeo-35 PTA Catheter |
12/05/2014 |
K222065 |
BioTronik, Inc. |
Passeo-35 Xeo Peripheral Dilatation Catheter |
02/16/2023 |
K041293 |
BIPORE, INC. |
BIOPORE BALLOON DILATION CATHETER |
07/09/2004 |
K961980 |
BIPORE, INC. |
BIPORE BALLOON DILATATION CATHETER |
09/12/1996 |
K973563 |
BIPORE, INC. |
BIPORE BALLOON DILATATION CATHETER |
04/01/1998 |
K983650 |
BIPORE, INC. |
BIPORE BALLOON DILATATION CATHETER |
02/17/1999 |
K073318 |
BIPORE, INC. |
BIPORE BALLOON DILATION CATHETER |
01/16/2008 |
K021996 |
Bolton Medical, Inc. |
BOLTON PTA CATHETER |
08/23/2002 |
K112697 |
BOSTON SCIENTIFIC |
CHARGER PTA BALLON DILATATION CATHETER |
11/30/2011 |
K113681 |
BOSTON SCIENTIFIC |
GLADIATOR PTA BALLOON DILATION CATHETER |
01/11/2012 |
K103751 |
BOSTON SCIENTIFIC |
MUSTANG BALLOON DILATATION CATHETERS |
03/22/2011 |
K141112 |
BOSTON SCIENTIFIC |
STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER |
07/16/2014 |
K143193 |
BOSTON SCIENTIFIC |
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters |
07/24/2015 |
K972357 |
BOSTON SCIENTIFIC CORP. |
BLUE MAX - 20 BALLOON DILATATION CATHETER |
11/19/1997 |
K071309 |
BOSTON SCIENTIFIC CORP. |
BLUE MAX BALLOON DILATATION CATHETER |
07/13/2007 |
K000570 |
BOSTON SCIENTIFIC CORP. |
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA |
04/13/2000 |
K970379 |
BOSTON SCIENTIFIC CORP. |
CHANNEL BALLOON CATHETER |
05/01/1997 |
K972744 |
BOSTON SCIENTIFIC CORP. |
COURIER ST BALLOON DILATATION CATHETER |
12/11/1997 |
K001134 |
BOSTON SCIENTIFIC CORP. |
GAZELLE BALLOON DILATATION CATHETER |
08/31/2000 |
K132810 |
BOSTON SCIENTIFIC CORP. |
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER |
02/28/2014 |
K992320 |
BOSTON SCIENTIFIC CORP. |
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER |
05/18/2000 |
K071042 |
BOSTON SCIENTIFIC CORP. |
POLARCATH PERIPHERAL DILATATION SYSTEM |
06/13/2007 |
K141150 |
BOSTON SCIENTIFIC CORP. |
PTA BALLOON DILATATION CATHETER |
09/25/2014 |
K080982 |
BOSTON SCIENTIFIC CORP. |
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS |
07/14/2008 |
K093636 |
BOSTON SCIENTIFIC CORP. |
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX |
12/23/2009 |
K132430 |
BOSTON SCIENTIFIC CORP. |
STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER |
10/17/2013 |
K093720 |
BOSTON SCIENTIFIC CORP. |
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO |
12/23/2009 |
K000798 |
BOSTON SCIENTIFIC CORP. |
TALON BALLOON DILATION CATHETER |
06/08/2000 |
K993305 |
BOSTON SCIENTIFIC CORP. |
TRANSLUMINAL BALLOON DILATATION CATHETER |
04/10/2000 |
K960501 |
BOSTON SCIENTIFIC CORP. |
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER |
04/09/1996 |
K150303 |
BOSTON SCIENTIFIC CORP. |
XXL Vascular Balloon Dilatation Catheter |
06/15/2015 |
K111295 |
Boston Scientific Corporation |
.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS |
05/31/2011 |
K201170 |
Boston Scientific Corporation |
Athletis PTA Balloon Dilatation Catheter |
09/15/2020 |
K060960 |
Boston Scientific Corporation |
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER |
04/12/2006 |
K162350 |
Boston Scientific Corporation |
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous |
11/04/2016 |
K092455 |
Boston Scientific Corporation |
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM |
09/04/2009 |
K141521 |
Boston Scientific Corporation |
MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER |
08/21/2014 |
K052038 |
Boston Scientific Corporation |
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM |
08/16/2005 |
K060959 |
Boston Scientific Corporation |
SYMMETRY BALLOON DILATATION CATHETER |
04/12/2006 |
K972512 |
BOSTON SCIENTIFIC SCIMED, INC. |
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL |
02/12/1998 |
K160941 |
Brosmed Medical Co., Ltd. |
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter |
12/13/2016 |
K160256 |
Brosmed Medical Co., Ltd. |
Polux , Minerva and Atropos PTA Balloon Dilatation Catheter |
07/29/2016 |
K212215 |
BrosMed Medical Co., Ltd. |
Tiche PTA Balloon Dilatation Catheter |
07/19/2022 |
K181323 |
C. R. Bard, Inc. |
Atlas Gold PTA Dilatation Catheter |
08/03/2018 |
K122984 |
C.R. BARD, INC. |
ATLAS GOLD PTA DILATATION CATHETER |
10/22/2012 |
K960517 |
C.R. BARD, INC. |
BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER |
04/09/1996 |
K223177 |
C.R. Bard, Inc. |
HighlanderÖ 014 PTA Balloon Dilatation Catheter |
01/20/2023 |
K130786 |
C.R. BARD, INC. |
SLEEK OTW PTA CATHETER |
05/03/2013 |
K093965 |
C.R. BARD, INC. |
ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS |
03/17/2010 |
K121856 |
C.R. BARD, INC. |
ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION |
07/11/2012 |
K073472 |
C.R. BARD, INC. |
VACCESS PTA BALLOON DILATATION CATHETER |
01/09/2008 |
K963688 |
CARDIOVASCULAR DYNAMICS, INC. |
FOCUS PV BALLOON DILATATION CATHETER |
03/28/1997 |
K971577 |
CARDIOVASCULAR DYNAMICS, INC. |
FOCUS-PV BALLOON DILATATION CATHETER |
06/18/1997 |
K093139 |
CLEAR STREAM TECHNOLOGIES, LTD. |
BANTAM,48XXXXXX, 50XXXXXX |
12/30/2009 |
K100490 |
CLEAR STREAM TECHNOLOGIES, LTD. |
LITEPAC, MODEL 682 |
03/16/2010 |
K102035 |
CLEAR STREAM TECHNOLOGIES, LTD. |
SLEEK OTW PTA CATHETERS |
12/01/2010 |
K101361 |
CLEARSTREAM TECHNOLOGIES, LTD. |
REEFLEX PTA CATHETER |
08/04/2010 |
K072947 |
CLEARSTREAM TECHNOLOGIES, LTD. |
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS |
02/08/2008 |
K221339 |
Contego Medical Inc. |
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection |
06/09/2022 |
K181128 |
Contego Medical, LLC |
Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) |
09/06/2018 |
K181529 |
Contego Medical, LLC |
Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection |
12/06/2018 |
K170193 |
COOK INCORPORATED |
Advance 14LP Low Profile PTA Balloon Dilatation Catheter |
02/13/2017 |
K130293 |
COOK, INC. |
ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
05/31/2013 |
K132020 |
COOK, INC. |
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
10/25/2013 |
K113300 |
COOK, INC. |
ATB ADVANCE PTA DILATATION CATHETER |
12/09/2011 |
K981906 |
COOK, INC. |
MODIFICATION FOR PTA BALLOON CATHETER |
06/29/1998 |
K023504 |
COOK, INC. |
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER |
11/13/2002 |
K001087 |
COOK, INC. |
PTA BALLOON CATHETER |
07/20/2000 |
K972800 |
COOK, INC. |
PTA BALLOON CATHETER |
04/16/1998 |
K980390 |
COOK, INC. |
PTA BALLOON CATHETER |
08/20/1998 |
K050645 |
CORDIS CORP. |
CORDIS AMIIA .014 PTA BALLOON CATHETER |
04/01/2005 |
K992825 |
CORDIS CORP. |
CORDIS EXTREME PTA BALLOON CATHETER |
09/15/1999 |
K991811 |
CORDIS CORP. |
CORDIS MAXI DS PTA BALLOON CATHETER |
06/15/1999 |
K971579 |
CORDIS CORP. |
CORDIS OPTA 5 PTA BALLOON CATHETER |
07/18/1997 |
K971448 |
CORDIS CORP. |
CORDIS OPTA LP PTA BALLOON CATHETER |
07/03/1997 |
K962945 |
CORDIS CORP. |
CORDIS OPTA PTA BALLOON CATHETER |
10/23/1996 |
K970620 |
CORDIS CORP. |
CORDIS OPTA5 PTA BALLOON CATHETER |
05/06/1997 |
K971516 |
CORDIS CORP. |
CORDIS POWERFLEX PLUS PTA BALLOON CATHETER |
07/23/1997 |
K003159 |
CORDIS CORP. |
CORDIS SLALOM PTA BALLOON CATHETER |
10/30/2000 |
K970299 |
CORDIS CORP. |
JUPITER PTA CATHETERS (VARIOUS) |
04/24/1997 |
K963000 |
CORDIS CORP. |
MAXI LD PTA BALLOON CATHETER |
02/20/1997 |
K955886 |
CORDIS CORP. |
MEGA PTA BALLOON CATHETER |
03/11/1996 |
K981407 |
CORDIS CORP. |
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER |
05/20/1998 |
K971010 |
CORDIS CORP. |
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS |
06/18/1997 |
K112797 |
CORDIS CORP. |
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER |
05/04/2012 |
K121442 |
CORDIS CORPORATION |
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER |
06/14/2012 |
K210626 |
Cordis Corporation |
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter |
04/23/2021 |
K201333 |
Cordis Corporation |
SABER .035 PTA Dilatation Catheter |
09/11/2020 |
K133843 |
CORDIS CORPORATION |
SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER |
06/27/2014 |
K201377 |
Cordis Corporation |
SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter |
10/09/2020 |
K063563 |
CORDIS EUROPA, N.V. |
CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER |
03/07/2007 |
K071189 |
CORDIS EUROPA, N.V. |
CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER |
05/16/2007 |
K221832 |
Cordis US Corp. |
SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter |
08/22/2022 |
K142654 |
Covidien LLC |
Fortrex 0.035 OTW PTA Balloon Catheter |
10/28/2014 |
K171251 |
Creagh Medical |
014 Hydrophilic Coated PTA Balloon Dilatation Catheter |
09/08/2017 |
K230191 |
Creagh Medical Ltd |
AriseÖ UHP Dilatation Catheter |
03/22/2023 |
K113468 |
CREAGH MEDICAL LTD |
ELM PTA BALLON DILATATION CATHETER |
12/20/2011 |
K102645 |
CREAGH MEDICAL LTD |
WILLOW/ELM PTA BALLOON DILATATION CATHETER |
12/10/2010 |
K200700 |
Creagh Medical Ltd. |
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter |
05/14/2020 |
K211044 |
Creagh Medical Ltd. (a wholly owned subsidiary of Surmodics, |
Sublime Radial Access 018 RX Dilatation Catheter |
06/16/2021 |
K180007 |
Creagh Medical, Ltd. |
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter |
04/19/2018 |
K030742 |
CRYO VASCULAR SYSTEMS INC. |
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM |
08/29/2003 |
K051916 |
CRYOVASCULAR SYSTEMS, INC. |
POLAR CATH PERIPHERAL DILATATION SYSTEM |
08/05/2005 |
K171290 |
Curatia Medical |
Vela RX PTA Balloon Dilatation Catheter |
07/19/2017 |
K214009 |
DK Medical Technology Co., Ltd. |
D╖Kaptain PTA High Pressure Balloon Dilatation Catheter |
04/05/2023 |
K110319 |
EV3 INC |
EVERCROSS 0.035 OTW PTA DILATATION CATHETER |
04/14/2011 |
K103322 |
EV3 INC |
EVERCROSS 0.035 OTW PTA DILATION CATHETER |
12/06/2010 |
K141118 |
EV3 INC |
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER |
07/18/2014 |
K132777 |
EV3 INC |
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER |
09/26/2013 |
K093286 |
EV3 INC |
POWERCROSS .018 OTW PTA DILATION CATHETER |
11/13/2009 |
K123544 |
EV3 INC |
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER |
02/12/2013 |
K130911 |
EV3 INC. |
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER |
05/24/2013 |
K000101 |
GUIDANT CORP. |
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER |
02/10/2000 |
K983055 |
GUIDANT CORP. |
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 |
12/30/1998 |
K993639 |
GUIDANT CORP. |
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER |
01/27/2000 |
K965183 |
GUIDANT CORP. |
VANTAGE PERIPHERAL DILATATION CATHETER |
04/24/1997 |
K130397 |
HOTSPUR TECHNOLOGIES |
ARROW GPSCATH BALLOON DILATATION CATHETER |
06/20/2013 |
K113769 |
HOTSPUR TECHNOLOGIES |
GPSCATH BALLON DILATATION CATHETER |
01/20/2012 |
K101047 |
HOTSPUR TECHNOLOGIES |
PTA-DUO PTA BALLOON CATHETER |
07/13/2010 |
K143093 |
HOTSPUR TECHNOLOGIES, INC., |
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) |
06/24/2015 |
K142300 |
HOTSPUR TECHNOLOGIES, INC., |
Arrow GPSCath Balloon Dialation Catheter (150 cm) |
09/17/2014 |
K140351 |
HOTSPUR TECHNOLOGIES,INC SUBSIDIARY OF TELEFLEX ME |
ARROW GPSCATH BALLOON DILATATION CATHETER |
07/02/2014 |
K192399 |
Infinity Angioplasty Balloon Company, LLC |
Infinity Angioplasty Balloon Catheter |
05/20/2020 |
K993913 |
INFINITY EXTRUSION & ENGINEERING, INC. |
TRUE |
08/09/2000 |
K100921 |
INVATEC S.P.A. |
ADMIRAL XTREME PTA BALLOON DILATATION CATHETER |
04/30/2010 |
K092361 |
INVATEC S.P.A. |
REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER |
10/29/2009 |
K020854 |
JOMED AG |
MODIFICATION TO FOX PTA CATHETER |
04/11/2002 |
K160013 |
KANEKA CORPORATION |
Crosperio OTW |
04/29/2016 |
K152887 |
Kaneka Corporation |
Crosperio RX PTA Balloon Dilatation Catheter |
01/22/2016 |
K160004 |
KANEKA CORPORATION |
Crosstella OTW |
04/29/2016 |
K152873 |
KANEKA CORPORATION |
Crosstella RX Balloon Dilatation Catheter |
01/22/2016 |
K152080 |
Kaneka Corporation |
Metacross OTW PTA Balloon Dilatation Catheter |
09/24/2015 |
K163479 |
KANEKA CORPORATION |
R2P Metacross RX |
01/11/2017 |
K221245 |
Kossel Medtech (Suzhou) Co., Ltd. |
PTA Balloon Dilatation Catheter |
12/14/2022 |
K983830 |
MALLINCKROOT, INC. |
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER |
04/16/1999 |
K953647 |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING |
05/16/1997 |
K953298 |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
MS CLASSIQUE BALLOON DIATATION CATHETER |
02/08/1996 |
K952884 |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER |
02/21/1996 |
K121265 |
MEDTRONIC INC. |
AMPHIRION PLUS PTA CATHETER |
05/22/2012 |
K103464 |
MEDTRONIC INC. |
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER |
12/22/2010 |
K173515 |
Medtronic Vascular |
Admiral Xtreme |
04/12/2018 |
K123358 |
MEDTRONIC VASCULAR |
PACIFIC PLUS |
01/29/2013 |
K202800 |
Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc) |
Pacific Plus PTA Catheter |
11/18/2020 |
K213631 |
Medtronic, Inc. |
Chocolate PTA Balloon Catheter |
12/15/2021 |
K190753 |
Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.) |
EverCrossTM 0.035 OTW PTA Dilatation Catheter |
04/23/2019 |
K173621 |
Merit Medical Systems Inc. |
Advocate PTA Catheter |
12/13/2017 |
K192907 |
Merit Medical Systems Inc. |
Advocate PTA Catheter |
11/26/2019 |
K152934 |
MicroMedical Solutions, Inc. |
MMS PTA Balloon Catheter |
04/25/2016 |
K152230 |
NATEC MEDICAL |
Ebony PTA .014 RX Pheripheral Dilatation Catheter |
09/03/2015 |
K103354 |
NATEC MEDICAL LTD |
EBONY PTA .035 PERIPHERAL DILATATION CATHETER |
02/23/2011 |
K112513 |
NATEC MEDICAL LTD |
EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER |
12/09/2011 |
K142459 |
NATEC MEDICAL LTD |
Ebony PTA 0.014 RX Peripheral Dilatation Catheter |
02/03/2015 |
K143041 |
Natec Medical Ltd |
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter |
06/04/2015 |
K143036 |
Natec Medical Ltd |
Ebony PTA 0.035 Peripheral Dilatation Catheter |
03/30/2015 |
K220410 |
Natec Medical Ltd. |
Ebony HP PTA OTW 0.035 Catheter |
06/29/2022 |
K191275 |
NexStep Medical |
AllÆInCath 035M PTA Balloon Dilatation Catheter |
01/15/2020 |
K151141 |
NIPRO MEDICAL CORPORATION |
Cronus HP - High Pressure Peripheral Balloon Catheter |
01/14/2016 |
K190037 |
Nipro Medical Corporation |
Cronus HP PTA Balloon Catheter |
10/24/2019 |
K152665 |
NUCYRO VASCULAR, LLC |
PolarCath Peripheral Dilatation System |
10/26/2015 |
K003972 |
NUMED, INC. |
NUMED GHOST II PTA CATHETERS |
01/11/2001 |
K003114 |
NUMED, INC. |
NUMED TYSHAK AND Z-MED PTV CATHETERS |
11/01/2000 |
K003052 |
NUMED, INC. |
NUMED TYSHAK II AND Z-MED II PTV CATHETERS |
11/01/2000 |
K003276 |
NUMED, INC. |
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 |
12/01/2000 |
K991977 |
NUMED, INC. |
TYSHAK, MODEL 102 AND Z-MED, MODEL 302 |
09/27/2000 |
K143561 |
O'CONNELL REGULATORY CONSULTANTS, INC. |
ELM PTA Balloon Dilatation Catheter |
05/19/2015 |
K202231 |
OrbusNeich Medical (Shenzhen) Co., Ltd. |
JADE |
12/10/2020 |
K201794 |
OrbusNeich Medical (Shenzhen) Co., Ltd. |
Jade |
07/28/2020 |
K173894 |
OrbusNeich Medical Trading Inc. |
Jade PTA Balloon Dilatation Catheter |
02/09/2018 |
K150946 |
OSTIAL CORPORATION |
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm |
05/08/2015 |
K133861 |
OSTIAL CORPORATION |
FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM |
07/02/2014 |
K121175 |
OSTIAL CORPORATION |
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM |
06/29/2012 |
K122379 |
OSTIAL CORPORATION |
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM |
09/05/2012 |
K102482 |
OSTIAL CORPORATION |
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM |
02/25/2011 |
K120738 |
OSTIAL CORPORATION |
FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM |
03/29/2012 |
K093970 |
PENUMBRA, INC. |
PICA CATHETER |
01/15/2010 |
K201246 |
QualiMed USA, LLC. |
PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) |
08/03/2021 |
K121385 |
R4 VASCULAR, INC. |
VECTOR |
06/14/2012 |
K131329 |
R4 VASCULAR, INC. |
VECTOR PTA BALLOON DILATATION CATHETER |
06/06/2013 |
K970466 |
RADIUS MEDICAL TECHNOLOGIES, INC. |
RADIUS PTCA GUIDEWIRE |
05/20/1997 |
K221414 |
Silk Road Medical, Inc. |
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter |
09/02/2022 |
K150452 |
Summa Therapeutics, LLC |
ComboCath OTW PTA Dilatation Catheter |
08/13/2015 |
K230263 |
Summa Therapeutics, LLC |
FinesseÖ Injectable PTA Balloon Dilatation Catheter |
05/26/2023 |
K142954 |
Texas Medical Technologies, Inc. |
PTA 14 Balloon Dilatation Catheter OTW |
05/28/2015 |
K120677 |
TRIREME MEDICAL INC |
CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) |
03/15/2012 |
K122070 |
TRIREME MEDICAL INC |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G |
08/15/2012 |
K101062 |
TRIREME MEDICAL INC |
GLIDER PTA BALLOON CATHETER |
05/12/2010 |
K121402 |
TRIREME MEDICAL, INC. |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G |
06/08/2012 |
K130414 |
TRIREME MEDICAL, INC. |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 |
06/15/2013 |
K973013 |
VAS-CATH, INC. |
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER |
06/19/1998 |
K970725 |
VAS-CATH, INC. |
OPTI-PLAST XL 5.5 F PTA CATHETER |
05/09/1997 |
K964881 |
VAS-CATH, INC. |
ULTRAVERSE PTA CATHETER |
05/28/1997 |
K143652 |
Vector Corporation LLC |
Vector PTA Balloon Dilatation Catheter |
02/26/2015 |