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
K102705 ABBOTT VASCULAR INC. ARMANDA 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
K882925 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ACS SCHWARTEN XT BALLOON DILATATION CATHETER 09/28/1988
K844972 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER 05/16/1985
K842556 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ADVANCED CARDIOVASCULAR BALLOON DILATA 08/10/1984
K851854 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO 08/05/1985
K853746 ADVANCED CARDIOVASCULAR SYSTEMS, INC. ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO 10/21/1985
K843501 ADVANCED CARDIOVASCULAR SYSTEMS, INC. BALLOON DILATION CATHETER 10/04/1984
K822245 ADVANCED CARDIOVASCULAR SYSTEMS, INC. INDEFLATOR 08/31/1982
K831403 ADVANCED CARDIOVASCULAR SYSTEMS, INC. LOW PROFILE STEERABLE BALLOON DILATA 06/08/1983
K843880 ADVANCED CARDIOVASCULAR SYSTEMS, INC. LOW PROFILE STEERABLE BALLOON DILATION 11/27/1984
K833248 ADVANCED CARDIOVASCULAR SYSTEMS, INC. LOW PROFILE STEERABLE-INTRAOPERATIVE 12/22/1983
K803057 AMERICAN EDWARDS LABORATORIES FOGARTY BALLON ANGIOPLASTY CATHETERS 01/13/1981
K832474 AMERICAN EDWARDS LABORATORIES FOGARTY-CHIN PERIPHERAL DILATION CATH 09/29/1983
K831659 AMERICAN EDWARDS LABORATORIES FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE 08/12/1983
K830733 AMERICAN EDWARDS LABORATORIES FORGARTY CHIN PERIPHERAL INTRAOPERATIVE 04/18/1983
K834220 AMERICAN EDWARDS LABORATORIES HYBRID PERIPHERAL DILATION CATHETER 01/27/1984
K834429 AMERICAN EDWARDS LABORATORIES PERIPHERAL DILATATION ANGIOPLASTY-CATH 08/10/1984
K991540 ANGIODYNAMICS, INC. WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER 09/29/1999
K872542 ANGIOMEDICS, INC. SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER 09/14/1987
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
K931384 APPLIED VASCULAR ENGINEERING, INC. AVE ALLIANCE DILATATION CATHETER 09/17/1993
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
K951248 B. BRAUN MEDICAL, INC. BRAUN PTA BALLOON CATHETER 06/22/1995
K930745 B. BRAUN MEDICAL, INC. BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER 05/19/1994
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
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
K894250 BAXTER HEALTHCARE CORP. LE PTA CATHETER 03/07/1990
K885247 BAXTER HEALTHCARE CORP. STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR 03/10/1989
K052757 BIOTRONIK AG PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER 10/28/2005
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
K041293 BIPORE, INC. BIOPORE BALLOON DILATION CATHETER 07/09/2004
K973563 BIPORE, INC. BIPORE BALLOON DILATATION CATHETER 04/01/1998
K983650 BIPORE, INC. BIPORE BALLOON DILATATION CATHETER 02/17/1999
K961980 BIPORE, INC. BIPORE BALLOON DILATATION CATHETER 09/12/1996
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
K922610 BOSTON SCIENTIFIC CORP. BALLOON DILATATION CATHETER 11/18/1992
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
K921254 BOSTON SCIENTIFIC CORP. BLUE MAX II BALLOON DDILATATION CATHETER 12/03/1992
K970379 BOSTON SCIENTIFIC CORP. CHANNEL BALLOON CATHETER 05/01/1997
K953569 BOSTON SCIENTIFIC CORP. COURIER BALLOON DILATATION CATHETER 12/20/1995
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
K910995 BOSTON SCIENTIFIC CORP. MEDI-TECH BALLOON DILATATION CATHETER 04/09/1991
K897106 BOSTON SCIENTIFIC CORP. MEDI-TECH DILATATION CATHETERS ULTRA THIN II 10/16/1990
K992320 BOSTON SCIENTIFIC CORP. MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER 05/18/2000
K901018 BOSTON SCIENTIFIC CORP. MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS 05/30/1990
K934191 BOSTON SCIENTIFIC CORP. NEW BLUE MAX BALLOON DILATATION CATHETER 12/09/1993
K896520 BOSTON SCIENTIFIC CORP. OWENS CATHETER 03/25/1991
K900094 BOSTON SCIENTIFIC CORP. PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER 10/31/1990
K071042 BOSTON SCIENTIFIC CORP. POLARCATH PERIPHERAL DILATATION SYSTEM 06/13/2007
K141150 BOSTON SCIENTIFIC CORP. PTA BALLOON DILATATION CATHETER 09/25/2014
K924276 BOSTON SCIENTIFIC CORP. SHORT TEGWIRE -- MODIFIED 11/10/1992
K897124 BOSTON SCIENTIFIC CORP. SMALL VESSEL BALLOON DILATATION CATHETER 07/17/1990
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
K924047 BOSTON SCIENTIFIC CORP. SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER 11/02/1992
K913689 BOSTON SCIENTIFIC CORP. SUB-4(TM), PERIPHERAL DILATATION CATHETER 10/16/1991
K953602 BOSTON SCIENTIFIC CORP. SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER 10/18/1995
K000798 BOSTON SCIENTIFIC CORP. TALON BALLOON DILATION CATHETER 06/08/2000
K911203 BOSTON SCIENTIFIC CORP. TEGWIRE (TM) 04/09/1991
K913391 BOSTON SCIENTIFIC CORP. TEGWIRE (TM) 11/05/1991
K993305 BOSTON SCIENTIFIC CORP. TRANSLUMINAL BALLOON DILATATION CATHETER 04/10/2000
K923611 BOSTON SCIENTIFIC CORP. ULTRA THIN BALLOON DILATATION CATHETER 11/04/1993
K924320 BOSTON SCIENTIFIC CORP. ULTRA THIN BALLOON DILATATION CATHETER 11/10/1993
K920547 BOSTON SCIENTIFIC CORP. ULTRA-THIN 05/06/1992
K960501 BOSTON SCIENTIFIC CORP. ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER 04/09/1996
K952063 BOSTON SCIENTIFIC CORP. XXL BALLON DILATATION CATHETER 11/14/1995
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
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
K942154 BOSTON SCIENTIFIC SCIMED, INC. SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS 08/18/1994
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
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
K942400 C.R. BARD, INC. BARD PERIPHERAL BALLOON DILATATION CATHETER 11/07/1994
K910822 C.R. BARD, INC. BARD PERIPHERAL BALLOON DILATATION CATHETER 08/29/1991
K960517 C.R. BARD, INC. BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER 04/09/1996
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
K890325 C.R. BARD, INC. USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP 03/15/1989
K830608 C.R. BARD, INC. USCI GRUNTZIG DILACA BALLOON DILATION 03/24/1983
K890405 C.R. BARD, INC. USCI PTA BALLOON DILATATION CATHETER 08/17/1989
K073472 C.R. BARD, INC. VACCESS PTA BALLOON DILATATION CATHETER 01/09/2008
K945943 CARDIO-DYNAMICS, INC. CVD PERIFLOW(TM) BALLOON DILATATION CATHETER 02/24/1995
K942150 CARDIO-DYNAMICS, INC. CVD SMALL VESSEL BALLOON DILATION CATHETER 08/02/1994
K954313 CARDIO-DYNAMICS, INC. FOCUS PC BALLOON DILATATION CATHETER 12/01/1995
K945693 CARDIOVASCULAR DYNAMICS, INC. CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER 08/17/1995
K945465 CARDIOVASCULAR DYNAMICS, INC. CVD SMALL VESSEL BALLOON DILATATION CATHETER 12/20/1994
K944016 CARDIOVASCULAR DYNAMICS, INC. FOCUS BALLOON DILATATION CATHETER 12/20/1994
K952064 CARDIOVASCULAR DYNAMICS, INC. FOCUS BALLOON DILATATION CATHETER 06/21/1995
K963688 CARDIOVASCULAR DYNAMICS, INC. FOCUS PV BALLOON DILATATION CATHETER 03/28/1997
K971577 CARDIOVASCULAR DYNAMICS, INC. FOCUS-PV BALLOON DILATATION CATHETER 06/18/1997
K910965 CATHETER SCIENCES CO. ECHOMARK CSI INTERFACE 09/17/1991
K903582 CATHETER SCIENCES CO. ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. 11/06/1990
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
K170193 COOK INCORPORATED Advance 14LP Low Profile PTA Balloon Dilatation Catheter 02/13/2017
K924358 COOK, INC. ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED 05/20/1993
K900677 COOK, INC. ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER 02/22/1991
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
K870215 COOK, INC. DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) 08/12/1987
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
K882052 COOK, INC. OMEGA NV(TM) BALLOON DILATATION CATHETER 09/14/1988
K980390 COOK, INC. PTA BALLOON CATHETER 08/20/1998
K001087 COOK, INC. PTA BALLOON CATHETER 07/20/2000
K972800 COOK, INC. PTA BALLOON CATHETER 04/16/1998
K050645 CORDIS CORP. CORDIS AMIIA .014 PTA BALLOON CATHETER 04/01/2005
K812168 CORDIS CORP. CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH. 08/31/1981
K992825 CORDIS CORP. CORDIS EXTREME PTA BALLOON CATHETER 09/15/1999
K991811 CORDIS CORP. CORDIS MAXI DS PTA BALLOON CATHETER 06/15/1999
K905698 CORDIS CORP. CORDIS OPTA 5 07/09/1991
K971579 CORDIS CORP. CORDIS OPTA 5 PTA BALLOON CATHETER 07/18/1997
K940868 CORDIS CORP. CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION 07/12/1994
K933236 CORDIS CORP. CORDIS OPTA 5(TM), MODIFICATION 12/27/1993
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
K844913 CORDIS CORP. CORDIS PTA CATHETER-PERCUTANEOUS CATHETER 08/20/1985
K880612 CORDIS CORP. CORDIS PTA DILATATION CATHETERS 07/28/1988
K942094 CORDIS CORP. CORDIS SAVVY PTA BALLOON CATHETER 11/01/1994
K003159 CORDIS CORP. CORDIS SLALOM PTA BALLOON CATHETER 10/30/2000
K894899 CORDIS CORP. EXPANSION OF THE CORDIS PTA DILATATION CATHETER 01/26/1990
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
K950119 CORDIS CORP. OPTA 5(TM) 5F PTA BALLOON CATHETER 05/17/1995
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
K946052 CORDIS CORP. POWERFLEX(TM) 5F PTA BALLOON CATHETER 03/03/1995
K121442 CORDIS CORPORATION POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER 06/14/2012
K133843 CORDIS CORPORATION SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER 06/27/2014
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
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
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
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
K890800 DATASCOPE CORP. ROTATING HEMOSTATIC VALVE 06/12/1989
K881088 DEVICES FOR VASCULAR INTERVENTION, INC. ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) 05/31/1988
K901601 DEVICES FOR VASCULAR INTERVENTION, INC. HOLLOW MOTOR DRIVE UNIT 07/06/1990
K874706 DEVICES FOR VASCULAR INTERVENTION, INC. MODIFIED SIMPSON PERIPHERAL ATHEROCATH 01/04/1988
K883346 DEVICES FOR VASCULAR INTERVENTION, INC. SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F 09/26/1988
K871011 DEVICES FOR VASCULAR INTERVENTION, INC. SIMPSON PERIPHERAL ATHEROCATH(TM) 05/14/1987
K902454 ENDOSONICS CORP. CATHSCANNER(R) PTA BALLOON DILATATION CATHETER 08/30/1990
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
K851080 G V MEDICAL, INC, GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE 06/20/1985
K911215 GESCO INTL., INC. GESCO PER-Q-CATH NEEDLE 06/06/1991
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
K993913 INFINITY EXTRUSION & ENGINEERING, INC. TRUE 08/09/2000
K901767 INTENSIVE TECHNOLOGY, INC. MODIFIED IVT PERIPHERAL ATHERECTOMY 06/28/1990
K896403 INTENSIVE TECHNOLOGY, INC. MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM 03/06/1990
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
K813331 KONIGSBERG INSTRUMENTS, INC. P51 ANGIOPLASTY PRESSURE TRANSDUCER 12/29/1981
K880158 L.O.N. RESEARCH, INC. ANGIOPLASTY BALLOON INFLATION DEVICE 03/22/1988
K902317 MALLINCKRODT MEDICAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH. 12/03/1990
K905773 MALLINCKRODT MEDICAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER 01/30/1991
K884481 MALLINCKROOT, INC. CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE 01/10/1989
K983830 MALLINCKROOT, INC. COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER 04/16/1999
K851848 MANSFIELD SCIENTIFIC, INC. PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER 07/19/1985
K923947 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX SURGIMED BALLOON CATHETER 09/30/1993
K933975 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM 10/06/1993
K942635 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM 11/01/1994
K934411 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE 01/07/1994
K904410 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) 03/25/1991
K921706 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R) 05/20/1993
K942293 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MS CLASSIQUE BALLOON CATHETER 10/18/1994
K943298 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. MS CLASSIQUE BALLOON CATHETER 09/08/1994
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
K944989 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. NOPROFILE OLBERT CATHETER SYSTEM 04/26/1995
K952884 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER 02/21/1996
K953608 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER 12/20/1995
K833616 MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. OLBERT CATHETER SYSTEM 12/26/1983
K862550 MEADOX SURGIMED, INC. OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE 09/02/1986
K843383 MEDI-TECH, INC. MEDI-TECH DILATATION CATHETERS 10/24/1984
K880298 MEDI-TECH, INC. PERIPHERAL DILATATION CATHETER 04/22/1988
K884327 MEDICAL PROFILES, INC. EXCEL Y-CONNECTOR CAT. #E-201 04/19/1989
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
K923638 MEDTRONICS INTERVENTIONAL VASCULAR ACESSORY PACK 02/08/1993
K940063 MEDTRONICS INTERVENTIONAL VASCULAR MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS 03/29/1994
K173621 Merit Medical Systems Inc. Advocate PTA Catheter 12/13/2017
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
K151141 NIPRO MEDICAL CORPORATION Cronus HP - High Pressure Peripheral Balloon Catheter 01/14/2016
K903606 NORTH AMERICAN INSTRUMENT CORP. GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER 09/27/1990
K152665 NUCYRO VASCULAR, LLC PolarCath Peripheral Dilatation System 10/26/2015
K003972 NUMED, INC. NUMED GHOST II PTA CATHETERS 01/11/2001
K871796 NUMED, INC. NUMED PTA CATHETERS 12/03/1987
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
K931009 NUMED, INC. TYSHAK PERIPHERAL BALLOON DILATION CATHETER 12/21/1993
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
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
K905250 PERINATAL SYSTEMS LOBOW 01/08/1991
K895179 PERIPHERAL SYSTEMS GROUP ACCESSOR PERIPHERAL DILATING GUIDE WIRE 02/28/1990
K904984 PERIPHERAL SYSTEMS GROUP ADVANCE 418(TM) 04/12/1991
K894944 PERIPHERAL SYSTEMS GROUP BALLOON DILATATION CATHETER 01/19/1990
K915168 PERIPHERAL SYSTEMS GROUP PROFLEX 5 02/19/1992
K934433 PERIPHERAL SYSTEMS GROUP VANTAGE DIALTAION CATHETER 12/09/1993
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
K915349 SCHNEIDER INTL., LTD. PTA BALLOON CATHETER 02/11/1992
K926271 SCHNEIDER INTL., LTD. SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO 06/07/1993
K913297 SCHNEIDER INTL., LTD. SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH 10/10/1991
K921943 SCHNEIDER INTL., LTD. SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL 06/17/1992
K912317 SCHNEIDER INTL., LTD. SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH 08/22/1991
K902091 SCHNEIDER INTL., LTD. SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER 09/26/1990
K911196 SCHNEIDER INTL., LTD. SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA) 06/10/1991
K921856 SCHNEIDER INTL., LTD. TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. 07/21/1992
K875175 SCHNEIDER-SHILLEY (USA) MODIFIED PERIPHERAL DILATATION CATHETERS 07/28/1988
K882826 SCHNEIDER-SHILLEY (USA) SOFTRAC-PTA PERIPHERAL DILATATION CATHETER 01/24/1989
K881197 SCHNEIDER-SHILLEY (USA) SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER 05/16/1988
K915347 SCIMED SCIMED VIPER CATHETER 08/17/1992
K925945 SCIMED LIFE SYSTEMS, INC. MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT 05/20/1993
K841961 SCIMED LIFE SYSTEMS, INC. MILLS OPERATIVE PERIPHERAL ANGIOPLASTY 10/23/1984
K850760 SCIMED LIFE SYSTEMS, INC. MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER 04/10/1985
K923826 SCIMED LIFE SYSTEMS, INC. PARAMETRIC PROCESS CONTROL 10/22/1992
K875064 SCIMED LIFE SYSTEMS, INC. SCIMED INFLATION DEVICE, MODEL SM 2000 02/29/1988
K934378 SCIMED LIFE SYSTEMS, INC. SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER 01/18/1994
K932537 SCIMED LIFE SYSTEMS, INC. SCIMED MAVERICK PTA CATHETER 12/08/1993
K910155 SCIMED LIFE SYSTEMS, INC. SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH 02/07/1991
K911870 SCIMED LIFE SYSTEMS, INC. SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH 08/12/1991
K850075 SCIMED LIFE SYSTEMS, INC. SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT 04/10/1985
K921577 SCIMED LIFE SYSTEMS, INC. SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER 10/16/1992
K933183 SCIMED LIFE SYSTEMS, INC. SCIMED VIPER 09/09/1993
K944815 SCIMED LIFE SYSTEMS, INC. SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER 11/14/1994
K934793 SCIMED PERIPHERAL INTERVENTIONS SCIMED MAVERICK 01/05/1994
K935501 SCIMED PERIPHERAL INTERVENTIONS SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING 01/27/1994
K854319 SHILEY, INC. SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER 03/31/1986
K862467 SHILEY, INC. SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR 08/11/1986
K150452 Summa Therapeutics, LLC ComboCath OTW PTA Dilatation Catheter 08/13/2015
K911089 TARGET THERAPEUTICS STEALTH CATHETER SYSTEM 05/29/1991
K893411 TARGET THERAPEUTICS STEALTH DILATION CATHETER SYSTEM 09/05/1989
K915895 TARGET THERAPEUTICS STEALTH DILATION CATHETER SYSTEM (MODIFIED) 06/04/1992
K142954 Texas Medical Technologies, Inc. PTA 14 Balloon Dilatation Catheter OTW 05/28/2015
K880194 THERATEK, INC. KENSEY CATHETER 04/18/1988
K911130 THOMAS MEDICAL PRODUCTS, INC. HEMOSTATIC Y CONNECTOR 06/06/1991
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
K933483 VAS-CATH, INC. OPTI-PLAST 5F PTA CATHETERS 09/24/1993
K910996 VAS-CATH, INC. OPTI-PLAST 5F PTA CATHETERS 04/09/1991
K913112 VAS-CATH, INC. OPTI-PLAST 5F PTA CATHETERS 08/16/1991
K911639 VAS-CATH, INC. OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE 06/11/1991
K914500 VAS-CATH, INC. OPTI-PLAST 5F PTA CATHETERS, MODIFICATION 12/31/1991
K914976 VAS-CATH, INC. OPTI-PLAST 5F PTA CATHETERS, MODIFICATION 01/27/1992
K912984 VAS-CATH, INC. OPTI-PLAST 5F PTA CATHETERS, MODIFICATION 08/13/1991
K902367 VAS-CATH, INC. OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER 12/03/1990
K941706 VAS-CATH, INC. OPTI-PLAST ANGIOPLASTY CATHETER 10/18/1994
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
K925485 VAS-CATH, INC. VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER 03/10/1994
K903417 VAS-CATH, INC. VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH 12/05/1990
K143652 Vector Corporation LLC Vector PTA Balloon Dilatation Catheter 02/26/2015


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