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403 FDA 510(k) clearances · Product code

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RecordFirmDate
PTA BALLOON CATHETER (K001087)Cook, Inc.2000-07-20
TALON BALLOON DILATION CATHETER (K000798)Boston Scientific Corp2000-06-08
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K992320)Boston Scientific Corp2000-05-18
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA (K000570)Boston Scientific Corp2000-04-13
TRANSLUMINAL BALLOON DILATATION CATHETER (K993305)Boston Scientific Corp2000-04-10
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER (K000101)Guidant Corp.2000-02-10
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER (K993639)Guidant Corp.2000-01-27
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (K991540)AngioDynamics, Inc.1999-09-29
CORDIS EXTREME PTA BALLOON CATHETER (K992825)Cordis Corp.1999-09-15
CORDIS MAXI DS PTA BALLOON CATHETER (K991811)Cordis Corp.1999-06-15
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER (K983830)Mallinckroot, Inc.1999-04-16
BIPORE BALLOON DILATATION CATHETER (K983650)Bipore, Inc.1999-02-17
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 (K983055)Guidant Corp.1998-12-30
PTA BALLOON CATHETER (K980390)Cook, Inc.1998-08-20
MODIFICATION FOR PTA BALLOON CATHETER (K981906)Cook, Inc.1998-06-29
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER (K973013)Vas-Cath, Inc.1998-06-19
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER (K981407)Cordis Corp.1998-05-20
PTA BALLOON CATHETER (K972800)Cook, Inc.1998-04-16
BIPORE BALLOON DILATATION CATHETER (K973563)Bipore, Inc.1998-04-01
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL (K972512)Boston Scientific Scimed, Inc.1998-02-12
COURIER ST BALLOON DILATATION CATHETER (K972744)Boston Scientific Corp1997-12-11
BLUE MAX - 20 BALLOON DILATATION CATHETER (K972357)Boston Scientific Corp1997-11-19
CORDIS POWERFLEX PLUS PTA BALLOON CATHETER (K971516)Cordis Corp.1997-07-23
CORDIS OPTA 5 PTA BALLOON CATHETER (K971579)Cordis Corp.1997-07-18
CORDIS OPTA LP PTA BALLOON CATHETER (K971448)Cordis Corp.1997-07-03
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS (K971010)Cordis Corp.1997-06-18
FOCUS-PV BALLOON DILATATION CATHETER (K971577)Cardiovascular Dynamics, Inc.1997-06-18
ULTRAVERSE PTA CATHETER (K964881)Vas-Cath, Inc.1997-05-28
RADIUS PTCA GUIDEWIRE (K970466)Radius Medical Technologies, Inc.1997-05-20
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING (K953647)Meadox Medicals, Div. Boston Scientific Corp.1997-05-16
OPTI-PLAST XL 5.5 F PTA CATHETER (K970725)Vas-Cath, Inc.1997-05-09
CORDIS OPTA5 PTA BALLOON CATHETER (K970620)Cordis Corp.1997-05-06
CHANNEL BALLOON CATHETER (K970379)Boston Scientific Corp1997-05-01
VANTAGE PERIPHERAL DILATATION CATHETER (K965183)Guidant Corp.1997-04-24
JUPITER PTA CATHETERS (VARIOUS) (K970299)Cordis Corp.1997-04-24
FOCUS PV BALLOON DILATATION CATHETER (K963688)Cardiovascular Dynamics, Inc.1997-03-28
MAXI LD PTA BALLOON CATHETER (K963000)Cordis Corp.1997-02-20
CORDIS OPTA PTA BALLOON CATHETER (K962945)Cordis Corp.1996-10-23
BIPORE BALLOON DILATATION CATHETER (K961980)Bipore, Inc.1996-09-12
BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER (K960517)C.R. Bard, Inc.1996-04-09
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER (K960501)Boston Scientific Corp1996-04-09
MEGA PTA BALLOON CATHETER (K955886)Cordis Corp.1996-03-11
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (K952884)Meadox Medicals, Div. Boston Scientific Corp.1996-02-21
MS CLASSIQUE BALLOON DIATATION CATHETER (K953298)Meadox Medicals, Div. Boston Scientific Corp.1996-02-08
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (K953608)Meadox Medicals, Div. Boston Scientific Corp.1995-12-20
COURIER BALLOON DILATATION CATHETER (K953569)Boston Scientific Corp1995-12-20
FOCUS PC BALLOON DILATATION CATHETER (K954313)Cardio-Dynamics, Inc.1995-12-01
XXL BALLON DILATATION CATHETER (K952063)Boston Scientific Corp1995-11-14
SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER (K953602)Boston Scientific Corp1995-10-18
CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER (K945693)Cardiovascular Dynamics, Inc.1995-08-17
BRAUN PTA BALLOON CATHETER (K951248)B.Braun Medical, Inc.1995-06-22
FOCUS BALLOON DILATATION CATHETER (K952064)Cardiovascular Dynamics, Inc.1995-06-21
OPTA 5(TM) 5F PTA BALLOON CATHETER (K950119)Cordis Corp.1995-05-17
NOPROFILE OLBERT CATHETER SYSTEM (K944989)Meadox Medicals, Div. Boston Scientific Corp.1995-04-26
POWERFLEX(TM) 5F PTA BALLOON CATHETER (K946052)Cordis Corp.1995-03-03
CVD PERIFLOW(TM) BALLOON DILATATION CATHETER (K945943)Cardio-Dynamics, Inc.1995-02-24
FOCUS BALLOON DILATATION CATHETER (K944016)Cardiovascular Dynamics, Inc.1994-12-20
CVD SMALL VESSEL BALLOON DILATATION CATHETER (K945465)Cardiovascular Dynamics, Inc.1994-12-20
SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K944815)Scimed Life Systems, Inc.1994-11-14
BARD PERIPHERAL BALLOON DILATATION CATHETER (K942400)C.R. Bard, Inc.1994-11-07
MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM (K942635)Meadox Medicals, Div. Boston Scientific Corp.1994-11-01
CORDIS SAVVY PTA BALLOON CATHETER (K942094)Cordis Corp.1994-11-01
MS CLASSIQUE BALLOON CATHETER (K942293)Meadox Medicals, Div. Boston Scientific Corp.1994-10-18
OPTI-PLAST ANGIOPLASTY CATHETER (K941706)Vas-Cath, Inc.1994-10-18
MS CLASSIQUE BALLOON CATHETER (K943298)Meadox Medicals, Div. Boston Scientific Corp.1994-09-08
SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS (K942154)Boston Scientific Scimed, Inc.1994-08-18
CVD SMALL VESSEL BALLOON DILATION CATHETER (K942150)Cardio-Dynamics, Inc.1994-08-02
CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION (K940868)Cordis Corp.1994-07-12
BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER (K930745)B.Braun Medical, Inc.1994-05-19
MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS (K940063)Medtronics Interventional Vascular1994-03-29
VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER (K925485)Vas-Cath, Inc.1994-03-10
SCIMED VIPER PTA CATHETER WITH BIOSLIDE HYDROPHILIC COATING (K935501)Scimed Peripheral Interventions1994-01-27
SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER (K934378)Scimed Life Systems, Inc.1994-01-18
MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE (K934411)Meadox Medicals, Div. Boston Scientific Corp.1994-01-07
SCIMED MAVERICK (K934793)Scimed Peripheral Interventions1994-01-05
CORDIS OPTA 5(TM), MODIFICATION (K933236)Cordis Corp.1993-12-27
TYSHAK PERIPHERAL BALLOON DILATION CATHETER (K931009)NuMED, Inc.1993-12-21
VANTAGE DIALTAION CATHETER (K934433)Peripheral Systems Group1993-12-09
NEW BLUE MAX BALLOON DILATATION CATHETER (K934191)Boston Scientific Corp1993-12-09
SCIMED MAVERICK PTA CATHETER (K932537)Scimed Life Systems, Inc.1993-12-08
ULTRA THIN BALLOON DILATATION CATHETER (K924320)Boston Scientific Corp1993-11-10
ULTRA THIN BALLOON DILATATION CATHETER (K923611)Boston Scientific Corp1993-11-04
MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM (K933975)Meadox Medicals, Div. Boston Scientific Corp.1993-10-06
MEADOX SURGIMED BALLOON CATHETER (K923947)Meadox Medicals, Div. Boston Scientific Corp.1993-09-30
OPTI-PLAST 5F PTA CATHETERS (K933483)Vas-Cath, Inc.1993-09-24
AVE ALLIANCE DILATATION CATHETER (K931384)Applied Vascular Engineering, Inc.1993-09-17
SCIMED VIPER (K933183)Scimed Life Systems, Inc.1993-09-09
SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO (K926271)Schneider Intl., Ltd.1993-06-07
ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED (K924358)Cook, Inc.1993-05-20
MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R) (K921706)Meadox Medicals, Div. Boston Scientific Corp.1993-05-20
MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT (K925945)Scimed Life Systems, Inc.1993-05-20
ACESSORY PACK (K923638)Medtronics Interventional Vascular1993-02-08
BLUE MAX II BALLOON DDILATATION CATHETER (K921254)Boston Scientific Corp1992-12-03
BALLOON DILATATION CATHETER (K922610)Boston Scientific Corp1992-11-18
SHORT TEGWIRE -- MODIFIED (K924276)Boston Scientific Corp1992-11-10
SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER (K924047)Boston Scientific Corp1992-11-02
PARAMETRIC PROCESS CONTROL (K923826)Scimed Life Systems, Inc.1992-10-22
SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER (K921577)Scimed Life Systems, Inc.1992-10-16
SCIMED VIPER CATHETER (K915347)Scimed1992-08-17
TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. (K921856)Schneider Intl., Ltd.1992-07-21
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