FDA Product Code
FDA Product Code LIT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 405 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132810 | GLADIATOR ELITE PTA BALLOON DILATATION CATHETER | Boston Scientific Corp | 2014-02-28 | Traditional | PDF ↗ |
| K133043 | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE | Angioslide, Ltd. | 2013-12-06 | Traditional | PDF ↗ |
| K132020 | ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER | Cook, Inc. | 2013-10-25 | Special | PDF ↗ |
| K132430 | STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER | Boston Scientific Corp | 2013-10-17 | Traditional | PDF ↗ |
| K132777 | NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER | Ev3, Inc. | 2013-09-26 | Traditional | PDF ↗ |
| K130397 | ARROW GPSCATH BALLOON DILATATION CATHETER | Hotspur Technologies | 2013-06-20 | Traditional | PDF ↗ |
| K130414 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 | Trireme Medical, Inc. | 2013-06-15 | Traditional | PDF ↗ |
| K131329 | VECTOR PTA BALLOON DILATATION CATHETER | R4 Vascular, Inc. | 2013-06-06 | Special | PDF ↗ |
| K130293 | ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER | Cook, Inc. | 2013-05-31 | Special | PDF ↗ |
| K131199 | ULTRAVERSE RX PTA BALLOON DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2013-05-30 | Traditional | PDF ↗ |
| K130911 | RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER | Ev3, Inc. | 2013-05-24 | Traditional | PDF ↗ |
| K130786 | SLEEK OTW PTA CATHETER | C.R. Bard, Inc. | 2013-05-03 | Special | PDF ↗ |
| K130161 | PASSEO-35 | Biotronik, Inc. | 2013-04-23 | Traditional | PDF ↗ |
| K123544 | RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER | Ev3, Inc. | 2013-02-12 | Traditional | PDF ↗ |
| K123358 | PACIFIC PLUS | Medtronic Vascular | 2013-01-29 | Traditional | PDF ↗ |
| K122984 | ATLAS GOLD PTA DILATATION CATHETER | C.R. Bard, Inc. | 2012-10-22 | Traditional | PDF ↗ |
| K122379 | FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM | Ostial Corporation | 2012-09-05 | Special | PDF ↗ |
| K122070 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G | Trireme Medical, Inc. | 2012-08-15 | Special | PDF ↗ |
| K121856 | ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION | C.R. Bard, Inc. | 2012-07-11 | Special | PDF ↗ |
| K121175 | FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM | Ostial Corporation | 2012-06-29 | Traditional | PDF ↗ |
| K121385 | VECTOR | R4 Vascular, Inc. | 2012-06-14 | Traditional | PDF ↗ |
| K121442 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | Cordis Corporation | 2012-06-14 | Special | PDF ↗ |
| K121402 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G | Trireme Medical, Inc. | 2012-06-08 | Special | PDF ↗ |
| K120164 | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE | Angioslide, Ltd. | 2012-06-08 | Traditional | PDF ↗ |
| K121265 | AMPHIRION PLUS PTA CATHETER | Medtronic, Inc. | 2012-05-22 | Special | PDF ↗ |
| K112797 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | Cordis Corp. | 2012-05-04 | Traditional | PDF ↗ |
| K120722 | RIVAL PTA DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2012-04-19 | Traditional | PDF ↗ |
| K120971 | ATLAS PTA BALLOON DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2012-04-19 | Traditional | PDF ↗ |
| K120805 | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE | Angioslide, Ltd. | 2012-04-13 | Special | PDF ↗ |
| K120738 | FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM | Ostial Corporation | 2012-03-29 | Special | PDF ↗ |
| K120677 | CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) | Trireme Medical, Inc. | 2012-03-15 | Special | PDF ↗ |
| K120660 | CONQUEST 40 PTA DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2012-03-15 | Traditional | PDF ↗ |
| K113769 | GPSCATH BALLON DILATATION CATHETER | Hotspur Technologies | 2012-01-20 | Special | PDF ↗ |
| K113681 | GLADIATOR PTA BALLOON DILATION CATHETER | Boston Scientific | 2012-01-11 | Special | PDF ↗ |
| K113468 | ELM PTA BALLON DILATATION CATHETER | Creagh Medical, Ltd. | 2011-12-20 | Special | PDF ↗ |
| K113300 | ATB ADVANCE PTA DILATATION CATHETER | Cook, Inc. | 2011-12-09 | Special | PDF ↗ |
| K112513 | EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER | Natec Medical , Ltd. | 2011-12-09 | Traditional | PDF ↗ |
| K112697 | CHARGER PTA BALLON DILATATION CATHETER | Boston Scientific | 2011-11-30 | Special | PDF ↗ |
| K111899 | ARMADA 35/35LL PTA CATHETER | Abbott Vascular | 2011-10-03 | Traditional | PDF ↗ |
| K111295 | .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS | Boston Scientific Corporation | 2011-05-31 | Special | PDF ↗ |
| K110319 | EVERCROSS 0.035 OTW PTA DILATATION CATHETER | Ev3, Inc. | 2011-04-14 | Special | PDF ↗ |
| K103751 | MUSTANG BALLOON DILATATION CATHETERS | Boston Scientific | 2011-03-22 | Traditional | PDF ↗ |
| K102482 | FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM | Ostial Corporation | 2011-02-25 | Traditional | PDF ↗ |
| K103354 | EBONY PTA .035 PERIPHERAL DILATATION CATHETER | Natec Medical , Ltd. | 2011-02-23 | Traditional | PDF ↗ |
| K103464 | PACIFIC XTREME PTCA BALLOON DILATATION CATHETER | Medtronic, Inc. | 2010-12-22 | Special | PDF ↗ |
| K102645 | WILLOW/ELM PTA BALLOON DILATATION CATHETER | Creagh Medical, Ltd. | 2010-12-10 | Traditional | PDF ↗ |
| K102705 | ARMADA 14 PTA CATHETER | Abbott Vascular, Inc. | 2010-12-07 | Traditional | PDF ↗ |
| K103322 | EVERCROSS 0.035 OTW PTA DILATION CATHETER | Ev3, Inc. | 2010-12-06 | Traditional | PDF ↗ |
| K102035 | SLEEK OTW PTA CATHETERS | ClearStream Technologies , Ltd. | 2010-12-01 | Special | PDF ↗ |
| K101361 | REEFLEX PTA CATHETER | ClearStream Technologies , Ltd. | 2010-08-04 | Traditional | PDF ↗ |
| K101047 | PTA-DUO PTA BALLOON CATHETER | Hotspur Technologies | 2010-07-13 | Traditional | PDF ↗ |
| K101062 | GLIDER PTA BALLOON CATHETER | Trireme Medical, Inc. | 2010-05-12 | Special | PDF ↗ |
| K100921 | ADMIRAL XTREME PTA BALLOON DILATATION CATHETER | Invatec S.P.A. | 2010-04-30 | Special | PDF ↗ |
| K090364 | EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE | Angioslide, Ltd. | 2010-03-23 | Traditional | PDF ↗ |
| K093965 | ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS | C.R. Bard, Inc. | 2010-03-17 | Traditional | PDF ↗ |
| K100490 | LITEPAC, MODEL 682 | ClearStream Technologies , Ltd. | 2010-03-16 | Special | PDF ↗ |
| K093970 | PICA CATHETER | Penumbra, Inc. | 2010-01-15 | Special | PDF ↗ |
| K093139 | BANTAM,48XXXXXX, 50XXXXXX | ClearStream Technologies , Ltd. | 2009-12-30 | Special | PDF ↗ |
| K093720 | STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO | Boston Scientific Corp | 2009-12-23 | Special | PDF ↗ |
| K093636 | STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX | Boston Scientific Corp | 2009-12-23 | Special | PDF ↗ |
| K093286 | POWERCROSS .018 OTW PTA DILATION CATHETER | Ev3, Inc. | 2009-11-13 | Special | PDF ↗ |
| K092361 | REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER | Invatec S.P.A. | 2009-10-29 | Traditional | PDF ↗ |
| K092455 | MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM | Boston Scientific Corporation | 2009-09-04 | Special | PDF ↗ |
| K092286 | FOX SV PTA CATHETER | Abbott Vascular | 2009-08-27 | Special | PDF ↗ |
| K080982 | STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS | Boston Scientific Corp | 2008-07-14 | Traditional | PDF ↗ |
| K081417 | FOXCROSS PTA CATHETER | Abbott Vascular, Inc. | 2008-06-04 | Special | PDF ↗ |
| K080925 | FOX PLUS PTA CATHETER | Abbott Vascular, Inc. | 2008-04-28 | Special | PDF ↗ |
| K080264 | MODIFICATION TO: FOX PLUS PTA CATHETER | Abbott Vascular-Vascular Solutions | 2008-03-26 | Special | PDF ↗ |
| K072947 | SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS | ClearStream Technologies , Ltd. | 2008-02-08 | Traditional | PDF ↗ |
| K072798 | VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER | Abbott Vascular-Vascular Solutions | 2008-01-31 | Traditional | PDF ↗ |
| K073318 | BIPORE BALLOON DILATION CATHETER | Bipore, Inc. | 2008-01-16 | Special | PDF ↗ |
| K073472 | VACCESS PTA BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 2008-01-09 | Special | PDF ↗ |
| K072765 | PASSEO 18 | Biotronik, Inc. | 2007-12-12 | Special | PDF ↗ |
| K072824 | FOX SV PTA CATHETER | Abbott Laboratories | 2007-10-23 | Special | PDF ↗ |
| K071309 | BLUE MAX BALLOON DILATATION CATHETER | Boston Scientific Corp | 2007-07-13 | Traditional | PDF ↗ |
| K071042 | POLARCATH PERIPHERAL DILATATION SYSTEM | Boston Scientific Corp | 2007-06-13 | Special | PDF ↗ |
| K071189 | CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER | Cordis Europa, N.V. | 2007-05-16 | Special | PDF ↗ |
| K063563 | CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER | Cordis Europa, N.V. | 2007-03-07 | Traditional | PDF ↗ |
| K062843 | FOX SV PTA CATHETER | Abbott Laboratories | 2006-10-17 | Special | PDF ↗ |
| K060959 | SYMMETRY BALLOON DILATATION CATHETER | Boston Scientific Corporation | 2006-04-12 | Traditional | PDF ↗ |
| K060960 | BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER | Boston Scientific Corporation | 2006-04-12 | Traditional | PDF ↗ |
| K052757 | PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER | Biotronik AG | 2005-10-28 | Special | PDF ↗ |
| K052038 | PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM | Boston Scientific Corporation | 2005-08-16 | Special | PDF ↗ |
| K051916 | POLAR CATH PERIPHERAL DILATATION SYSTEM | Cryo Vascular Systems, Inc. | 2005-08-05 | Special | PDF ↗ |
| K051042 | METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 | Angiometrx, Inc. | 2005-08-05 | Traditional | PDF ↗ |
| K051519 | FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) | Abbott Laboratories (Perclose, Inc.) | 2005-06-21 | Special | PDF ↗ |
| K050645 | CORDIS AMIIA .014 PTA BALLOON CATHETER | Cordis Corp. | 2005-04-01 | Special | PDF ↗ |
| K041293 | BIOPORE BALLOON DILATION CATHETER | Bipore, Inc. | 2004-07-09 | Abbreviated | PDF ↗ |
| K040954 | FOX PLUS PTA CATHETER | Abbott Laboratories, Inc. | 2004-05-11 | Special | PDF ↗ |
| K030742 | POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM | Cryo Vascular Systems, Inc. | 2003-08-29 | Traditional | PDF ↗ |
| K030062 | ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 | Avantec Vascular Corp. | 2003-04-03 | Traditional | PDF ↗ |
| K023504 | MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER | Cook, Inc. | 2002-11-13 | Special | PDF ↗ |
| K021996 | BOLTON PTA CATHETER | Bolton Medical, Inc. | 2002-08-23 | Traditional | PDF ↗ |
| K020854 | MODIFICATION TO FOX PTA CATHETER | Jomed AG | 2002-04-11 | Special | PDF ↗ |
| K003972 | NUMED GHOST II PTA CATHETERS | NuMED, Inc. | 2001-01-11 | Special | PDF ↗ |
| K003276 | TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 | NuMED, Inc. | 2000-12-01 | Traditional | PDF ↗ |
| K003114 | NUMED TYSHAK AND Z-MED PTV CATHETERS | NuMED, Inc. | 2000-11-01 | Special | PDF ↗ |
| K003052 | NUMED TYSHAK II AND Z-MED II PTV CATHETERS | NuMED, Inc. | 2000-11-01 | Special | PDF ↗ |
| K003159 | CORDIS SLALOM PTA BALLOON CATHETER | Cordis Corp. | 2000-10-30 | Special | PDF ↗ |
| K991977 | TYSHAK, MODEL 102 AND Z-MED, MODEL 302 | NuMED, Inc. | 2000-09-27 | Traditional | PDF ↗ |
Product code LIT · Class II · Cardiovascular. Data: openFDA.