FDA 510(k) Applications for Medical Device Product Code "LIT"
(Catheter, Angioplasty, Peripheral, Transluminal)
| 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 |
| K241711 | Biotronik, Inc. | Oscar Peripheral Multifunctional Catheter system | 07/11/2024 |
| 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 |
| K250706 | BIOTRONIK, Inc. | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pante | 04/04/2025 |
| 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 |
| K241683 | Boston Scientific Corporation | SterlingÖ MONORAILÖ PTA Balloon Dilatation Catheter (H74939031404020 ); SterlingÖ MONORAILÖ PTA Balloon Dilatation Catheter (H74939031406020); SterlingÖ MONORAILÖ PTA Balloon Dilatation Catheter (H74939031408020); SterlingÖ MONORAILÖ PTA Balloon Dilatatio | 07/10/2024 |
| 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 |
| K243704 | BrosMed Medical Co., Ltd. | Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter | 02/27/2025 |
| 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 |
| K242419 | Creagh Medical Ltd. dba Surmodics, Inc. | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | 11/15/2024 |
| 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 |
| K231402 | Kossel Medtech (Suzhou) Co.,Ltd. | HP PTA Balloon Dilatation Catheter | 12/20/2023 |
| 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 |
| K241040 | Natec Medical Ltd. | Amethyst HP PTA OTW 0.035 Catheter | 12/18/2024 |
| 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 |
| K241025 | OrbusNeich Medical (Shenzhen) Co., Ltd. | JADE PLUS PTA Balloon Dilatation Catheter | 06/11/2024 |
| 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 |
| K241740 | Summa Therapeutics | Finesse InjectableÖ PTA Balloon Dilatation Catheter | 07/16/2024 |
| 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 |
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