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 |
|---|---|---|---|
| Aug 31, 2000 | K001134 | GAZELLE BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Aug 9, 2000 | K993913 | TRUE Infinity Extrusion & Engineering, Inc. | LIT |
| Jul 20, 2000 | K001087 | PTA BALLOON CATHETER Cook, Inc. | LIT |
| Jun 8, 2000 | K000798 | TALON BALLOON DILATION CATHETER Boston Scientific Corp | LIT |
| May 18, 2000 | K992320 | MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Boston Scientific Corp | LIT |
| Apr 13, 2000 | K000570 | BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA Boston Scientific Corp | LIT |
| Apr 10, 2000 | K993305 | TRANSLUMINAL BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Feb 10, 2000 | K000101 | RX VIATRAC 14 PERIPHERAL DILATATION CATHETER Guidant Corp. | LIT |
| Jan 27, 2000 | K993639 | RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER Guidant Corp. | LIT |
| Sep 29, 1999 | K991540 | WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER AngioDynamics, Inc. | LIT |
| Sep 15, 1999 | K992825 | CORDIS EXTREME PTA BALLOON CATHETER Cordis Corp. | LIT |
| Jun 15, 1999 | K991811 | CORDIS MAXI DS PTA BALLOON CATHETER Cordis Corp. | LIT |
| Apr 16, 1999 | K983830 | COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER Mallinckroot, Inc. | LIT |
| Feb 17, 1999 | K983650 | BIPORE BALLOON DILATATION CATHETER Bipore, Inc. | LIT |
| Dec 30, 1998 | K983055 | RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 Guidant Corp. | LIT |
| Aug 20, 1998 | K980390 | PTA BALLOON CATHETER Cook, Inc. | LIT |
| Jun 29, 1998 | K981906 | MODIFICATION FOR PTA BALLOON CATHETER Cook, Inc. | LIT |
| Jun 19, 1998 | K973013 | OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER Vas-Cath, Inc. | LIT |
| May 20, 1998 | K981407 | OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER Cordis Corp. | LIT |
| Apr 16, 1998 | K972800 | PTA BALLOON CATHETER Cook, Inc. | LIT |
| Apr 1, 1998 | K973563 | BIPORE BALLOON DILATATION CATHETER Bipore, Inc. | LIT |
| Feb 12, 1998 | K972512 | SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL Boston Scientific Scimed, Inc. | LIT |
| Dec 11, 1997 | K972744 | COURIER ST BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Nov 19, 1997 | K972357 | BLUE MAX - 20 BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Jul 23, 1997 | K971516 | CORDIS POWERFLEX PLUS PTA BALLOON CATHETER Cordis Corp. | LIT |
| Jul 18, 1997 | K971579 | CORDIS OPTA 5 PTA BALLOON CATHETER Cordis Corp. | LIT |
| Jul 3, 1997 | K971448 | CORDIS OPTA LP PTA BALLOON CATHETER Cordis Corp. | LIT |
| Jun 18, 1997 | K971577 | FOCUS-PV BALLOON DILATATION CATHETER Cardiovascular Dynamics, Inc. | LIT |
| Jun 18, 1997 | K971010 | PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS Cordis Corp. | LIT |
| May 28, 1997 | K964881 | ULTRAVERSE PTA CATHETER Vas-Cath, Inc., CA | LIT |
| May 20, 1997 | K970466 | RADIUS PTCA GUIDEWIRE Radius Medical Technologies, Inc. | LIT |
| May 16, 1997 | K953647 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| May 9, 1997 | K970725 | OPTI-PLAST XL 5.5 F PTA CATHETER Vas-Cath, Inc., CA | LIT |
| May 6, 1997 | K970620 | CORDIS OPTA5 PTA BALLOON CATHETER Cordis Corp. | LIT |
| May 1, 1997 | K970379 | CHANNEL BALLOON CATHETER Boston Scientific Corp | LIT |
| Apr 24, 1997 | K970299 | JUPITER PTA CATHETERS (VARIOUS) Cordis Corp. | LIT |
| Apr 24, 1997 | K965183 | VANTAGE PERIPHERAL DILATATION CATHETER Guidant Corp. | LIT |
| Mar 28, 1997 | K963688 | FOCUS PV BALLOON DILATATION CATHETER Cardiovascular Dynamics, Inc. | LIT |
| Feb 20, 1997 | K963000 | MAXI LD PTA BALLOON CATHETER Cordis Corp. | LIT |
| Oct 23, 1996 | K962945 | CORDIS OPTA PTA BALLOON CATHETER Cordis Corp. | LIT |
| Sep 12, 1996 | K961980 | BIPORE BALLOON DILATATION CATHETER Bipore, Inc. | LIT |
| Apr 9, 1996 | K960517 | BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER C.R. Bard, Inc. | LIT |
| Apr 9, 1996 | K960501 | ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Mar 11, 1996 | K955886 | MEGA PTA BALLOON CATHETER Cordis Corp. | LIT |
| Feb 21, 1996 | K952884 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Feb 8, 1996 | K953298 | MS CLASSIQUE BALLOON DIATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Dec 20, 1995 | K953608 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. | LIT |
| Dec 20, 1995 | K953569 | COURIER BALLOON DILATATION CATHETER Boston Scientific Corp | LIT |
| Dec 1, 1995 | K954313 | FOCUS PC BALLOON DILATATION CATHETER Cardio-Dynamics, Inc. | LIT |
| Nov 14, 1995 | K952063 | XXL BALLON DILATATION CATHETER Boston Scientific Corp | LIT |
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