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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS MODEL 250 (P790007/S012)Medtronic Heart Valves1993-12-08
GEMNOS(TM)04A CARDIAC PACEMAKER & SWM 600/C00U02 (P820076/S015)Biotronik, Inc.1993-12-08
SCHNEIDER FREEHAND(TM) MODELS FH20-20,25,30,35,40 (P880027/S029)Boston Scientific1993-12-07
VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S003)Carbomedics, Inc.1993-12-07
ROTABLATOR(R) (P900056/S005)Boston Scientific Corp1993-12-07
CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S027)Medtronic Cardiac Rhythm Disease Management1993-12-06
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S006)Abiomed Cardiovascular, Inc.1993-11-23
EXCIMER LASER (P900032/S020)Spectranetics Corp.1993-11-23
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S005)Abiomed Cardiovascular, Inc.1993-11-23
SCIMED(R) SC COBRA(TM) 14 PTCA CATHETER (P860019/S071)Scimed Life Systems, Inc.1993-11-08
RX ELIPSE(TM) .014 CORONARY DILITATION CATHETER (P810046/S146)Advanced Cardiovascular Systems, Inc.1993-11-08
MEDTRONIC ELITE II MODEL 7086 (P890003/S021)Medtronic, Inc.1993-11-08
MEDTRONIC(R)PANTHER(TM) CORONARY BALL. DILI. CATH. (P870036/S027)Medtronics Interventional Vascular1993-11-05
MEDTRONIC(R) RAIDER(TM) CORONARY BALL. DILI. CATH. (P870036/S026)Medtronics Interventional Vascular1993-11-04
EXCIMER LASER MODEL DYMER (R) 200+ (P900032/S015)Spectranetics Corp.1993-10-25
HYBRID (PTCA) CATHETER (P850021/S024)Abbott Vascular, Inc.1993-10-25
PTCA BALLOON DILITATION CATHETERS (P840040/S038)Boston Scientific Corp1993-10-21
ACS RX ELIPSE(TM) .014 CORONARY DILITATION CATH. (P810046/S140)Advanced Cardiovascular Systems, Inc.1993-10-21
EXCIMER LASER (LASER CATHETER-MODEL PC4030(2.0MM)) (P900032/S003)Spectranetics Corp.1993-10-19
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S001)Spectranetics Corp.1993-10-18
ACS SPACTRUM(TM) CORONARY DILATATION CATHETER (P810046/S145)Advanced Cardiovascular Systems, Inc.1993-10-13
CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE (P810046/S124)Advanced Cardiovascular Systems, Inc.1993-09-30
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060)Corcym S.r.l.1993-09-29
LOW PRESSURE BIOPROSTHESIS (MODELS 6625LP & 6625) (P870077/S001)Edwards Lifesciences, LLC1993-09-24
COOK BIRD'S NEST VENA CAVA FILTER (P850049/S003)Cook, Inc.1993-09-23
SCHNEIDER FREEHAND (TM) PTCA CATHETER (P880027/S027)Boston Scientific1993-09-23
CORDIS OLYMPIX,SLEEK, & PREDATOR PTCA CATHETERS (P880003/S016)Cordis Corp.1993-09-23
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S002)Spectranetics Corp.1993-09-23
SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC + (P810002/S026)ABBOTT MEDICAL1993-09-23
ACS RX ELIPSE & ELIPSE II CORO.DIL. CATHETERS (P810046/S127)Advanced Cardiovascular Systems, Inc.1993-09-14
SCIMED(R) ACE(TM) 1CM TIP PTCA CATHETER (P860019/S073)Scimed Life Systems, Inc.1993-09-13
SCIMED(R) LONG RALLY (TM) PTCA CATHETER (P860019/S069)Scimed Life Systems, Inc.1993-09-03
ACS CORONARY DILATATION CATHETERS (P810046/S142)Advanced Cardiovascular Systems, Inc.1993-09-02
SIEMENS PACESETTER MODEL 3070 (P830045/S045)St. Jude Medical, Inc.1993-09-02
GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) (P910030/S001)Cook, Inc.1993-08-30
MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER (P870036/S021)Medtronics Interventional Vascular1993-08-27
CCS MODEL 325 PACEMAKER SYSTEM (P890039/S011)Cardiac Control Systems, Inc.1993-08-26
ENDOTAK LEAD SYSTEM (P910073)Boston Scientific1993-08-26
ACS RX FLOWTRACK (TM) 40 CORO. DILITATION CATH. (P810046/S141)Advanced Cardiovascular Systems, Inc.1993-08-24
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S004)Abiomed Cardiovascular, Inc.1993-08-20
CORDIS PREDATOR PTCA DILITATION CATHETER (P880003/S015)Cordis Corp.1993-08-20
SYNERGY(TM) CONVERTIBLE RAPID EXCHANGE PTCA CATH. (P840040/S039)Boston Scientific Corp1993-08-17
EXCIMER LASER MODEL PC4016(1.3MM),4026(1.6MM) (P900032/S006)Spectranetics Corp.1993-08-12
SCHNEIDER PTCA CATHETER (P880027/S026)Boston Scientific1993-08-12
MEDTRONIC MODEL 5424 ELECTROCARDIOGRAM CABLE (P890003/S023)Medtronic, Inc.1993-08-10
MEDTRONIC MODEL 5423 ECG CABLE (P820003/S067)Medtronic Cardiac Rhythm Disease Management1993-08-10
MEDTRONIC(R) 14K(TM)CORONARY BALL DILATATION CATH (P870036/S024)Medtronics Interventional Vascular1993-08-09
ACS CORONARY DILATATION CATHETERS (P810046/S139)Advanced Cardiovascular Systems, Inc.1993-08-06
MEDTRONIC(R) SPIRIT(TM) CORONARY BALL. DILAT. CATH (P870036/S023)Medtronics Interventional Vascular1993-08-06
COSMOS II MODELS 284-05,283-03 PULSE GENERATOR (P830026/S058)Boston Scientific1993-08-04
MEDTRONIC(R) MODEL 5346 TEMPORARY PULSE GENERATOR (P820003/S065)Medtronic Cardiac Rhythm Disease Management1993-08-04
INTERTACH(R)II MODELS 262-16 (P860007/S012)Boston Scientific1993-08-04
CORDIS PTCA DILATATION CATHETERS (P880003/S019)Cordis Corp.1993-08-02
CORDIS SLEEK PTCA DILATATION CATHETERS (P880003/S018)Cordis Corp.1993-07-29
SCIMED(R) PIVOT (TM) PTCA CATHETER (P860019/S074)Scimed Life Systems, Inc.1993-07-29
STACK PERFUSION IV CORONARY DILATION CATHETER (P810046/S122)Advanced Cardiovascular Systems, Inc.1993-07-29
ACS EDGE(TM) CORONARY DILITATION CATHETER (P810046/S130)Advanced Cardiovascular Systems, Inc.1993-07-23
SCIMED QUANTUM(TM) PTCA CATHETER (P860019/S052)Scimed Life Systems, Inc.1993-07-21
CORDIS PREDATOR PTCA DILITATION CATHETER (P880003/S014)Cordis Corp.1993-07-21
CHANGES TO PINKERTON & OMEGA CORO.DIL. CATHETERS (P810046/S126)Advanced Cardiovascular Systems, Inc.1993-07-21
ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S001)Abiomed Cardiovascular, Inc.1993-07-12
SLIDER (TM)3.4F LONG BALLOON DILATATION PTCA CATH (P840040/S037)Boston Scientific Corp1993-07-08
CHANGES TO ALPHA /STREAK ADD BALLOON LENGTHS (P810046/S125)Advanced Cardiovascular Systems, Inc.1993-07-07
SLEEK PTCA DILATATION CATHETERS W/3 & 4CM BALLONS (P880003/S013)Cordis Corp.1993-07-07
MEDTRONIC MODEL 8360 MICRO MINIX (P850051/S039)Medtronic, Inc.1993-07-02
HANCOCK BIOPROSTHESIS MODELS 242,342,343C,342R (P870078/S003)Medtronic, Inc.1993-07-02
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS (P790007/S011)Medtronic Heart Valves1993-07-02
SCIMED(R) NC RALLY(TM) PTCA CATHETER (P860019/S068)Scimed Life Systems, Inc.1993-07-01
REACH(TM).14 PTCA CATHETER (P850021/S022)Abbott Vascular, Inc.1993-07-01
META DDDR PACING SYSTEM MODEL 1254/FUNC.1250H (P900070/S001)St. Jude Medical, Cardiac Rhythm Management Divisi1993-06-29
CCS MODEL 333 PACEMAKER SYSTEM (P890039/S008)Cardiac Control Systems, Inc.1993-06-24
EXCIMER LASER (LASER CATHETER-MODEL PC4010(1.3MM)) (P900032/S001)Spectranetics Corp.1993-06-22
EXCIMER LASER (LASER CATHETER-MODEL PC4021(1.6MM)) (P900032/S002)Spectranetics Corp.1993-06-22
MODEL 9600 NETWORK PROGRAMMER (P820018/S058)St. Jude Medical, Inc.1993-06-18
OLYMPIX & SLEUTH XT PTCA CATHETERS W/3CM BALLOONS (P880003/S011)Cordis Corp.1993-06-17
MODEL 9600 VERSION SC.11 PERSONALITY MODULE SOFT (P880038/S023)St. Jude Medical, Inc.1993-06-17
CORDIS ORION II STEERABLE BALLOON CATHETER (P890032/S014)Cordis Corp.1993-06-17
OLYMPIX & SLEUTH XT PTCA CATHETERS W/4CM BALLOONS (P880003/S012)Cordis Corp.1993-06-17
SLEEK PTCA DILATION CATHETER (P880003/S010)Cordis Corp.1993-06-17
SCIMED(R) PTCA CATHETER SHADOW(TM)P-14 (P860019/S056)Scimed Life Systems, Inc.1993-06-15
SCIMED(R) PTCA CATHETER NC COBRA 14 (P860019/S066)Scimed Life Systems, Inc.1993-06-15
SCIMED(R) PTCA CATHETER NC COBRA 14 (P860019/S067)Scimed Life Systems, Inc.1993-06-14
AFP CARDIAC PACING SYSTEM (P830045/S042)St. Jude Medical, Inc.1993-06-04
SOLUS (R) MODELS 2002,2003,SYNCHRONY(R)2022,2023 (P880086/S021)ABBOTT MEDICAL1993-06-04
USCI(R) SPRINT(TM) BALL. DIL. CATH. WITH BANKA(TM) (P790017/S043)Medtronic, Ireland1993-06-04
MEDTRONIC MODEL 9858 A SOFTWARE DISKETTES (P890003/S020)Medtronic, Inc.1993-06-03
MAESTRO(R) RELEASE III SOFTWARE 5OO SERIES (P860027/S009)Cardiac Control Systems, Inc.1993-06-03
ROTABLATOR(R) (P900056)Boston Scientific Corp1993-05-28
USCI(R)SOLITAIRE(TM) BALL.DIL.CATH.W/PRO/PEL(TM) (P790017/S046)Medtronic, Ireland1993-05-20
USCI(R) XPRT(TM) BALL. DIL. CATH. W/PRO/PEL(TM) (P790017/S047)Medtronic, Ireland1993-05-20
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019)Intensive Technology, Inc.1993-05-18
MEDTRONIC LEGEND II,MICRO MINIX MODIFICATIONS (P850051/S038)Medtronic, Inc.1993-05-18
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM (P840029/S007)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD ETS(TM) FLANGED GRAFT (P840029/S004)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM (P840029/S006)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT (P840029/S014)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD (R) MICROVEL (R) DOUBLE VELOUR (P840029/S011)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S010)Maquet Cardiovascular, LLC1993-05-11
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S009)Maquet Cardiovascular, LLC1993-05-11
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S005)Maquet Cardiovascular, LLC1993-05-11
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