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 |
|---|---|---|---|
| Jul 13, 2010 | K101047 | PTA-DUO PTA BALLOON CATHETER Hotspur Technologies | LIT |
| May 12, 2010 | K101062 | GLIDER PTA BALLOON CATHETER Trireme Medical, Inc. | LIT |
| Apr 30, 2010 | K100921 | ADMIRAL XTREME PTA BALLOON DILATATION CATHETER Invatec S.P.A. | LIT |
| Mar 23, 2010 | K090364 | EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE Angioslide, Ltd. | LIT |
| Mar 17, 2010 | K093965 | ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS C.R. Bard, Inc. | LIT |
| Mar 16, 2010 | K100490 | LITEPAC, MODEL 682 ClearStream Technologies , Ltd., IE | LIT |
| Jan 15, 2010 | K093970 | PICA CATHETER Penumbra, Inc. | LIT |
| Dec 30, 2009 | K093139 | BANTAM,48XXXXXX, 50XXXXXX ClearStream Technologies , Ltd., IE | LIT |
| Dec 23, 2009 | K093720 | STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO Boston Scientific Corp | LIT |
| Dec 23, 2009 | K093636 | STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX Boston Scientific Corp | LIT |
| Nov 13, 2009 | K093286 | POWERCROSS .018 OTW PTA DILATION CATHETER Ev3, Inc. | LIT |
| Oct 29, 2009 | K092361 | REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER Invatec S.P.A. | LIT |
| Sep 4, 2009 | K092455 | MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation | LIT |
| Aug 27, 2009 | K092286 | FOX SV PTA CATHETER Abbott Vascular | LIT |
| Jul 14, 2008 | K080982 | STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS Boston Scientific Corp | LIT |
| Jun 4, 2008 | K081417 | FOXCROSS PTA CATHETER Abbott Vascular, Inc. | LIT |
| Apr 28, 2008 | K080925 | FOX PLUS PTA CATHETER Abbott Vascular, Inc. | LIT |
| Mar 26, 2008 | K080264 | MODIFICATION TO: FOX PLUS PTA CATHETER Abbott Vascular-Vascular Solutions | LIT |
| Feb 8, 2008 | K072947 | SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS ClearStream Technologies , Ltd. | LIT |
| Jan 31, 2008 | K072798 | VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER Abbott Vascular-Vascular Solutions | LIT |
| Jan 16, 2008 | K073318 | BIPORE BALLOON DILATION CATHETER Bipore, Inc. | LIT |
| Jan 9, 2008 | K073472 | VACCESS PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. | LIT |
| Dec 12, 2007 | K072765 | PASSEO 18 Biotronik, Inc. | LIT |
| Oct 23, 2007 | K072824 | FOX SV PTA CATHETER Abbott Laboratories | LIT |
| Jul 13, 2007 | K071309 | BLUE MAX BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Jun 13, 2007 | K071042 | POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corp | LIT |
| May 16, 2007 | K071189 | CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER Cordis Europa, N.V., NL | LIT |
| Mar 7, 2007 | K063563 | CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER Cordis Europa, N.V. | LIT |
| Oct 17, 2006 | K062843 | FOX SV PTA CATHETER Abbott Laboratories | LIT |
| Apr 12, 2006 | K060960 | BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER Boston Scientific Corporation | LIT |
| Apr 12, 2006 | K060959 | SYMMETRY BALLOON DILATATION CATHETER Boston Scientific Corporation | LIT |
| Oct 28, 2005 | K052757 | PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Biotronik AG | LIT |
| Aug 16, 2005 | K052038 | PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM Boston Scientific Corporation | LIT |
| Aug 5, 2005 | K051916 | POLAR CATH PERIPHERAL DILATATION SYSTEM Cryo Vascular Systems, Inc. | LIT |
| Aug 5, 2005 | K051042 | METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000 Angiometrx, Inc., CA | LIT |
| Jun 21, 2005 | K051519 | FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) Abbott Laboratories (Perclose, Inc.) | LIT |
| Apr 1, 2005 | K050645 | CORDIS AMIIA .014 PTA BALLOON CATHETER Cordis Corp. | LIT |
| Jul 9, 2004 | K041293 | BIOPORE BALLOON DILATION CATHETER Bipore, Inc. | LIT |
| May 11, 2004 | K040954 | FOX PLUS PTA CATHETER Abbott Laboratories, Inc. | LIT |
| Aug 29, 2003 | K030742 | POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM Cryo Vascular Systems, Inc. | LIT |
| Apr 3, 2003 | K030062 | ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 Avantec Vascular Corp. | LIT |
| Nov 13, 2002 | K023504 | MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER Cook, Inc. | LIT |
| Aug 23, 2002 | K021996 | BOLTON PTA CATHETER Bolton Medical, Inc. | LIT |
| Apr 11, 2002 | K020854 | MODIFICATION TO FOX PTA CATHETER Jomed AG | LIT |
| Jan 11, 2001 | K003972 | NUMED GHOST II PTA CATHETERS NuMED, Inc. | LIT |
| Dec 1, 2000 | K003276 | TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107 NuMED, Inc. | LIT |
| Nov 1, 2000 | K003114 | NUMED TYSHAK AND Z-MED PTV CATHETERS NuMED, Inc. | LIT |
| Nov 1, 2000 | K003052 | NUMED TYSHAK II AND Z-MED II PTV CATHETERS NuMED, Inc. | LIT |
| Oct 30, 2000 | K003159 | CORDIS SLALOM PTA BALLOON CATHETER Cordis Corp. | LIT |
| Sep 27, 2000 | K991977 | TYSHAK, MODEL 102 AND Z-MED, MODEL 302 NuMED, Inc. | LIT |
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