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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001134 | GAZELLE BALLOON DILATATION CATHETER | Boston Scientific Corp | 2000-08-31 | Traditional | PDF ↗ |
| K993913 | TRUE | Infinity Extrusion & Engineering, Inc. | 2000-08-09 | Traditional | PDF ↗ |
| K001087 | PTA BALLOON CATHETER | Cook, Inc. | 2000-07-20 | Special | PDF ↗ |
| K000798 | TALON BALLOON DILATION CATHETER | Boston Scientific Corp | 2000-06-08 | Traditional | PDF ↗ |
| K992320 | MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER | Boston Scientific Corp | 2000-05-18 | Traditional | PDF ↗ |
| K000570 | BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA | Boston Scientific Corp | 2000-04-13 | Special | PDF ↗ |
| K993305 | TRANSLUMINAL BALLOON DILATATION CATHETER | Boston Scientific Corp | 2000-04-10 | Traditional | PDF ↗ |
| K000101 | RX VIATRAC 14 PERIPHERAL DILATATION CATHETER | Guidant Corp. | 2000-02-10 | Special | PDF ↗ |
| K993639 | RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER | Guidant Corp. | 2000-01-27 | Traditional | PDF ↗ |
| K991540 | WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER | AngioDynamics, Inc. | 1999-09-29 | Traditional | PDF ↗ |
| K992825 | CORDIS EXTREME PTA BALLOON CATHETER | Cordis Corp. | 1999-09-15 | Special | PDF ↗ |
| K991811 | CORDIS MAXI DS PTA BALLOON CATHETER | Cordis Corp. | 1999-06-15 | Special | PDF ↗ |
| K983830 | COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER | Mallinckroot, Inc. | 1999-04-16 | Traditional | PDF ↗ |
| K983650 | BIPORE BALLOON DILATATION CATHETER | Bipore, Inc. | 1999-02-17 | Traditional | PDF ↗ |
| K983055 | RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 | Guidant Corp. | 1998-12-30 | Traditional | PDF ↗ |
| K980390 | PTA BALLOON CATHETER | Cook, Inc. | 1998-08-20 | Traditional | PDF ↗ |
| K981906 | MODIFICATION FOR PTA BALLOON CATHETER | Cook, Inc. | 1998-06-29 | Special | PDF ↗ |
| K973013 | OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER | Vas-Cath, Inc. | 1998-06-19 | Traditional | PDF ↗ |
| K981407 | OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER | Cordis Corp. | 1998-05-20 | Special | PDF ↗ |
| K972800 | PTA BALLOON CATHETER | Cook, Inc. | 1998-04-16 | Traditional | PDF ↗ |
| K973563 | BIPORE BALLOON DILATATION CATHETER | Bipore, Inc. | 1998-04-01 | Traditional | PDF ↗ |
| K972512 | SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL | Boston Scientific Scimed, Inc. | 1998-02-12 | Traditional | PDF ↗ |
| K972744 | COURIER ST BALLOON DILATATION CATHETER | Boston Scientific Corp | 1997-12-11 | Traditional | PDF ↗ |
| K972357 | BLUE MAX - 20 BALLOON DILATATION CATHETER | Boston Scientific Corp | 1997-11-19 | Traditional | PDF ↗ |
| K971516 | CORDIS POWERFLEX PLUS PTA BALLOON CATHETER | Cordis Corp. | 1997-07-23 | Traditional | PDF ↗ |
| K971579 | CORDIS OPTA 5 PTA BALLOON CATHETER | Cordis Corp. | 1997-07-18 | Traditional | PDF ↗ |
| K971448 | CORDIS OPTA LP PTA BALLOON CATHETER | Cordis Corp. | 1997-07-03 | Traditional | PDF ↗ |
| K971577 | FOCUS-PV BALLOON DILATATION CATHETER | Cardiovascular Dynamics, Inc. | 1997-06-18 | Traditional | PDF ↗ |
| K971010 | PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS | Cordis Corp. | 1997-06-18 | Traditional | PDF ↗ |
| K964881 | ULTRAVERSE PTA CATHETER | Vas-Cath, Inc. | 1997-05-28 | Traditional | PDF ↗ |
| K970466 | RADIUS PTCA GUIDEWIRE | Radius Medical Technologies, Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K953647 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING | Meadox Medicals, Div. Boston Scientific Corp. | 1997-05-16 | Traditional | PDF ↗ |
| K970725 | OPTI-PLAST XL 5.5 F PTA CATHETER | Vas-Cath, Inc. | 1997-05-09 | Traditional | PDF ↗ |
| K970620 | CORDIS OPTA5 PTA BALLOON CATHETER | Cordis Corp. | 1997-05-06 | Traditional | PDF ↗ |
| K970379 | CHANNEL BALLOON CATHETER | Boston Scientific Corp | 1997-05-01 | Traditional | PDF ↗ |
| K970299 | JUPITER PTA CATHETERS (VARIOUS) | Cordis Corp. | 1997-04-24 | Traditional | PDF ↗ |
| K965183 | VANTAGE PERIPHERAL DILATATION CATHETER | Guidant Corp. | 1997-04-24 | Traditional | PDF ↗ |
| K963688 | FOCUS PV BALLOON DILATATION CATHETER | Cardiovascular Dynamics, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K963000 | MAXI LD PTA BALLOON CATHETER | Cordis Corp. | 1997-02-20 | Traditional | PDF ↗ |
| K962945 | CORDIS OPTA PTA BALLOON CATHETER | Cordis Corp. | 1996-10-23 | Traditional | PDF ↗ |
| K961980 | BIPORE BALLOON DILATATION CATHETER | Bipore, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K960501 | ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER | Boston Scientific Corp | 1996-04-09 | Traditional | PDF ↗ |
| K960517 | BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 1996-04-09 | Traditional | PDF ↗ |
| K955886 | MEGA PTA BALLOON CATHETER | Cordis Corp. | 1996-03-11 | Traditional | PDF ↗ |
| K952884 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-21 | Traditional | PDF ↗ |
| K953298 | MS CLASSIQUE BALLOON DIATATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-08 | Traditional | PDF ↗ |
| K953569 | COURIER BALLOON DILATATION CATHETER | Boston Scientific Corp | 1995-12-20 | Traditional | PDF ↗ |
| K953608 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1995-12-20 | Traditional | PDF ↗ |
| K954313 | FOCUS PC BALLOON DILATATION CATHETER | Cardio-Dynamics, Inc. | 1995-12-01 | Traditional | PDF ↗ |
| K952063 | XXL BALLON DILATATION CATHETER | Boston Scientific Corp | 1995-11-14 | Traditional | PDF ↗ |
| K953602 | SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER | Boston Scientific Corp | 1995-10-18 | Traditional | PDF ↗ |
| K945693 | CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER | Cardiovascular Dynamics, Inc. | 1995-08-17 | Traditional | PDF ↗ |
| K951248 | BRAUN PTA BALLOON CATHETER | B.Braun Medical, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K952064 | FOCUS BALLOON DILATATION CATHETER | Cardiovascular Dynamics, Inc. | 1995-06-21 | Traditional | PDF ↗ |
| K950119 | OPTA 5(TM) 5F PTA BALLOON CATHETER | Cordis Corp. | 1995-05-17 | Traditional | PDF ↗ |
| K944989 | NOPROFILE OLBERT CATHETER SYSTEM | Meadox Medicals, Div. Boston Scientific Corp. | 1995-04-26 | Traditional | PDF ↗ |
| K946052 | POWERFLEX(TM) 5F PTA BALLOON CATHETER | Cordis Corp. | 1995-03-03 | Traditional | PDF ↗ |
| K945943 | CVD PERIFLOW(TM) BALLOON DILATATION CATHETER | Cardio-Dynamics, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K945465 | CVD SMALL VESSEL BALLOON DILATATION CATHETER | Cardiovascular Dynamics, Inc. | 1994-12-20 | Traditional | PDF ↗ |
| K944016 | FOCUS BALLOON DILATATION CATHETER | Cardiovascular Dynamics, Inc. | 1994-12-20 | Traditional | PDF ↗ |
| K944815 | SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER | Scimed Life Systems, Inc. | 1994-11-14 | Traditional | PDF ↗ |
| K942400 | BARD PERIPHERAL BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 1994-11-07 | Traditional | PDF ↗ |
| K942635 | MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM | Meadox Medicals, Div. Boston Scientific Corp. | 1994-11-01 | Traditional | PDF ↗ |
| K942094 | CORDIS SAVVY PTA BALLOON CATHETER | Cordis Corp. | 1994-11-01 | Traditional | PDF ↗ |
| K941706 | OPTI-PLAST ANGIOPLASTY CATHETER | Vas-Cath, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K942293 | MS CLASSIQUE BALLOON CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1994-10-18 | Traditional | PDF ↗ |
| K943298 | MS CLASSIQUE BALLOON CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1994-09-08 | Traditional | PDF ↗ |
| K942154 | SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS | Boston Scientific Scimed, Inc. | 1994-08-18 | Traditional | PDF ↗ |
| K942150 | CVD SMALL VESSEL BALLOON DILATION CATHETER | Cardio-Dynamics, Inc. | 1994-08-02 | Traditional | PDF ↗ |
| K940868 | CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION | Cordis Corp. | 1994-07-12 | Traditional | PDF ↗ |
| K930745 | BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER | B.Braun Medical, Inc. | 1994-05-19 | Traditional | PDF ↗ |
| K940063 | MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS | Medtronics Interventional Vascular | 1994-03-29 | Traditional | PDF ↗ |
| K925485 | VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER | Vas-Cath, Inc. | 1994-03-10 | Traditional | PDF ↗ |
| K935501 | SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING | Scimed Peripheral Interventions | 1994-01-27 | Traditional | PDF ↗ |
| K934378 | SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER | Scimed Life Systems, Inc. | 1994-01-18 | Traditional | PDF ↗ |
| K934411 | MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE | Meadox Medicals, Div. Boston Scientific Corp. | 1994-01-07 | Traditional | PDF ↗ |
| K934793 | SCIMED MAVERICK | Scimed Peripheral Interventions | 1994-01-05 | Traditional | PDF ↗ |
| K933236 | CORDIS OPTA 5(TM), MODIFICATION | Cordis Corp. | 1993-12-27 | Traditional | PDF ↗ |
| K931009 | TYSHAK PERIPHERAL BALLOON DILATION CATHETER | NuMED, Inc. | 1993-12-21 | Traditional | PDF ↗ |
| K934191 | NEW BLUE MAX BALLOON DILATATION CATHETER | Boston Scientific Corp | 1993-12-09 | Traditional | PDF ↗ |
| K934433 | VANTAGE DIALTAION CATHETER | Peripheral Systems Group | 1993-12-09 | Traditional | PDF ↗ |
| K932537 | SCIMED MAVERICK PTA CATHETER | Scimed Life Systems, Inc. | 1993-12-08 | Traditional | PDF ↗ |
| K924320 | ULTRA THIN BALLOON DILATATION CATHETER | Boston Scientific Corp | 1993-11-10 | Traditional | PDF ↗ |
| K923611 | ULTRA THIN BALLOON DILATATION CATHETER | Boston Scientific Corp | 1993-11-04 | Traditional | PDF ↗ |
| K933975 | MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM | Meadox Medicals, Div. Boston Scientific Corp. | 1993-10-06 | Traditional | PDF ↗ |
| K923947 | MEADOX SURGIMED BALLOON CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | 1993-09-30 | Traditional | PDF ↗ |
| K933483 | OPTI-PLAST 5F PTA CATHETERS | Vas-Cath, Inc. | 1993-09-24 | Traditional | PDF ↗ |
| K931384 | AVE ALLIANCE DILATATION CATHETER | Applied Vascular Engineering, Inc. | 1993-09-17 | Traditional | PDF ↗ |
| K933183 | SCIMED VIPER | Scimed Life Systems, Inc. | 1993-09-09 | Traditional | PDF ↗ |
| K926271 | SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO | Schneider Intl., Ltd. | 1993-06-07 | Traditional | PDF ↗ |
| K921706 | MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R) | Meadox Medicals, Div. Boston Scientific Corp. | 1993-05-20 | Traditional | PDF ↗ |
| K925945 | MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT | Scimed Life Systems, Inc. | 1993-05-20 | Traditional | PDF ↗ |
| K924358 | ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED | Cook, Inc. | 1993-05-20 | Traditional | PDF ↗ |
| K923638 | ACESSORY PACK | Medtronics Interventional Vascular | 1993-02-08 | Traditional | PDF ↗ |
| K921254 | BLUE MAX II BALLOON DDILATATION CATHETER | Boston Scientific Corp | 1992-12-03 | Traditional | PDF ↗ |
| K922610 | BALLOON DILATATION CATHETER | Boston Scientific Corp | 1992-11-18 | Traditional | PDF ↗ |
| K924276 | SHORT TEGWIRE -- MODIFIED | Boston Scientific Corp | 1992-11-10 | Traditional | PDF ↗ |
| K924047 | SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER | Boston Scientific Corp | 1992-11-02 | Traditional | PDF ↗ |
| K923826 | PARAMETRIC PROCESS CONTROL | Scimed Life Systems, Inc. | 1992-10-22 | Traditional | PDF ↗ |
| K921577 | SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER | Scimed Life Systems, Inc. | 1992-10-16 | Traditional | PDF ↗ |
Product code LIT · Class II · Cardiovascular. Data: openFDA.