Panels › Cardiovascular › Product code LIT · Class 2
Catheter, Angioplasty, Peripheral, Transluminal
Regulation 870.1250
5510(k)s in 12 months (405 all time)
2recalls in 12 months (32 all time)
28recalls that name a 510(k)
Top companies in LIT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 2014 | K132810 | GLADIATOR ELITE PTA BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Dec 6, 2013 | K133043 | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE Angioslide, Ltd. | LIT |
| Oct 25, 2013 | K132020 | ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER Cook, Inc. | LIT |
| Oct 17, 2013 | K132430 | STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Sep 26, 2013 | K132777 | NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER Ev3, Inc. | LIT |
| Jun 20, 2013 | K130397 | ARROW GPSCATH BALLOON DILATATION CATHETER Hotspur Technologies | LIT |
| Jun 15, 2013 | K130414 | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018 Trireme Medical, Inc. | LIT |
| Jun 6, 2013 | K131329 | VECTOR PTA BALLOON DILATATION CATHETER R4 Vascular, Inc. | LIT |
| May 31, 2013 | K130293 | ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER Cook, Inc. | LIT |
| May 30, 2013 | K131199 | ULTRAVERSE RX PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. | LIT |
| May 24, 2013 | K130911 | RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER Ev3, Inc. | LIT |
| May 3, 2013 | K130786 | SLEEK OTW PTA CATHETER C.R. Bard, Inc., IE | LIT |
| Apr 23, 2013 | K130161 | PASSEO-35 Biotronik, Inc. | LIT |
| Feb 12, 2013 | K123544 | RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER Ev3, Inc. | LIT |
| Jan 29, 2013 | K123358 | PACIFIC PLUS Medtronic Vascular | LIT |
| Oct 22, 2012 | K122984 | ATLAS GOLD PTA DILATATION CATHETER C.R. Bard, Inc. | LIT |
| Sep 5, 2012 | K122379 | FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM Ostial Corporation | LIT |
| Aug 15, 2012 | 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. | LIT |
| Jul 11, 2012 | K121856 | ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION C.R. Bard, Inc. | LIT |
| Jun 29, 2012 | K121175 | FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM Ostial Corporation | LIT |
| Jun 14, 2012 | K121442 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Cordis Corporation | LIT |
| Jun 14, 2012 | K121385 | VECTOR R4 Vascular, Inc. | LIT |
| Jun 8, 2012 | 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. | LIT |
| Jun 8, 2012 | K120164 | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE Angioslide, Ltd. | LIT |
| May 22, 2012 | K121265 | AMPHIRION PLUS PTA CATHETER Medtronic, Inc. | LIT |
| May 4, 2012 | K112797 | POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Cordis Corp. | LIT |
| Apr 19, 2012 | K120971 | ATLAS PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. | LIT |
| Apr 19, 2012 | K120722 | RIVAL PTA DILATATION CATHETER Bard Peripheral Vascular, Inc. | LIT |
| Apr 13, 2012 | K120805 | PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE Angioslide, Ltd. | LIT |
| Mar 29, 2012 | K120738 | FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM Ostial Corporation | LIT |
| Mar 15, 2012 | K120677 | CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) Trireme Medical, Inc. | LIT |
| Mar 15, 2012 | K120660 | CONQUEST 40 PTA DILATATION CATHETER Bard Peripheral Vascular, Inc. | LIT |
| Jan 20, 2012 | K113769 | GPSCATH BALLON DILATATION CATHETER Hotspur Technologies | LIT |
| Jan 11, 2012 | K113681 | GLADIATOR PTA BALLOON DILATION CATHETER Boston Scientific | LIT |
| Dec 20, 2011 | K113468 | ELM PTA BALLON DILATATION CATHETER Creagh Medical, Ltd. | LIT |
| Dec 9, 2011 | K113300 | ATB ADVANCE PTA DILATATION CATHETER Cook, Inc. | LIT |
| Dec 9, 2011 | K112513 | EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER Natec Medical , Ltd. | LIT |
| Nov 30, 2011 | K112697 | CHARGER PTA BALLON DILATATION CATHETER Boston Scientific | LIT |
| Oct 3, 2011 | K111899 | ARMADA 35/35LL PTA CATHETER Abbott Vascular | LIT |
| May 31, 2011 | K111295 | .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS Boston Scientific Corporation | LIT |
| Apr 14, 2011 | K110319 | EVERCROSS 0.035 OTW PTA DILATATION CATHETER Ev3, Inc. | LIT |
| Mar 22, 2011 | K103751 | MUSTANG BALLOON DILATATION CATHETERS Boston Scientific | LIT |
| Feb 25, 2011 | K102482 | FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM Ostial Corporation | LIT |
| Feb 23, 2011 | K103354 | EBONY PTA .035 PERIPHERAL DILATATION CATHETER Natec Medical , Ltd. | LIT |
| Dec 22, 2010 | K103464 | PACIFIC XTREME PTCA BALLOON DILATATION CATHETER Medtronic, Inc. | LIT |
| Dec 10, 2010 | K102645 | WILLOW/ELM PTA BALLOON DILATATION CATHETER Creagh Medical, Ltd. | LIT |
| Dec 7, 2010 | K102705 | ARMADA 14 PTA CATHETER Abbott Vascular, Inc. | LIT |
| Dec 6, 2010 | K103322 | EVERCROSS 0.035 OTW PTA DILATION CATHETER Ev3, Inc. | LIT |
| Dec 1, 2010 | K102035 | SLEEK OTW PTA CATHETERS ClearStream Technologies , Ltd., IE | LIT |
| Aug 4, 2010 | K101361 | REEFLEX PTA CATHETER ClearStream Technologies , Ltd., IE | LIT |
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