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Cardiovascular

19,134 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER (K952884)Meadox Medicals, Div. Boston Scientific Corp.1996-02-21
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT (K955381)B.Braun Medical, Inc.1996-02-21
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC (K955349)Meadox Medicals, Div. Boston Scientific Corp.1996-02-14
RESPITRACE PT (K942852)Non-Invasive Monitoring Systems, Inc.1996-02-13
RESPIEVENTS (K942771)Non-Invasive Monitoring Systems, Inc.1996-02-13
MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) (K954284)Medi-Plast Intl., Inc.1996-02-12
A-V IMPULSE SYSTEM MODEL 6060 (K953648)Novamedix , Ltd.1996-02-12
VASCUTEK GELSOFT PLUS VASCULAR GRAFT (K955230)Vascutek, Ltd.1996-02-09
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM (K955396)Boston Scientific Corp1996-02-09
AMBULATORY (HOLTER) RECORDING SYSTEM (K950723)Biosensor Corp.1996-02-09
MS CLASSIQUE BALLOON DIATATION CATHETER (K953298)Meadox Medicals, Div. Boston Scientific Corp.1996-02-08
EPIC INTRODUCER SHEATH (K960310)North American Instrument Corp.1996-02-07
FIBERED PLATINUM COIL, .035 TYPE (K955293)Target Therapeutics1996-02-06
CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE (K954388)Conmedcorp1996-02-06
ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG (K954282)Statcorp, Inc.1996-02-06
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE (K953564)Medtronic Cardiac Surgery, Medtronic, Inc.1996-02-02
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD (K955801)Terumo Medical Corp.1996-02-02
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (K954848)Meadox Medicals, Div. Boston Scientific Corp.1996-02-01
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) (K954714)Pacesetter, Inc.1996-02-01
MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER (K955111)Adam Spence Corp.1996-01-31
MARS DIGITAL BLOOD PRESSURE MONITOR (K945215)Mars Metal Co., Ltd.1996-01-31
JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM (K943803)Janus Biomedical, Inc.1996-01-30
MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F) (K952984)Map Medical Equipment, Inc.1996-01-29
OMEGA CARES SYSTEM (K945068)J-F Medical Systems Intl., Inc.1996-01-25
MEDTRONIC SHERPA GUIDING CATHETER (K955651)Medtronics Interventional Vascular1996-01-22
STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE (K950990)Stoeckert Instrumente1996-01-19
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY (K954604)Heart Technology Mfg., Inc.1996-01-18
LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM (K952329)Progressive Dynamics, Inc.1996-01-17
LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER (K951096)Instromedix, Inc.1996-01-16
SCIMED ANGIOGRAPHIC KITS (K953265)Scimed Life Systems, Inc.1996-01-16
BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM (K954501)Medtronic Bio-Medicus, Inc.1996-01-16
PACEART CARDIOVOICE (K952065)Paceart, Inc.1996-01-16
SOFT VENOUS RESERVOIR (K955046)Gish Biomedical, Inc.1996-01-11
PEDIATRIC QUIK-COMBO (K953204)Physio-Control Corp.1996-01-11
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS (K954431)Boston Scientific Corp1996-01-11
TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM (K952659)Tronomed, Inc.1996-01-11
HOLTER 6000 (K950988)Omega Medical Services, Inc.1996-01-04
HEARTSTART 911 (K954609)Laerdal Medical Corp.1996-01-04
MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE (K954020)Micro Therapeutics, Inc.1996-01-02
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 (K950856)Zoll Medical Corp1995-12-29
LIFEPAK 11 (K951593)Physio-Control Corp.1995-12-29
CORDIS BRITE TIP SHEATH INTRODUCER (K954595)Cordis Corp.1995-12-28
DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR (K952494)Nihon Seimitsu Sokki Co., Ltd.1995-12-28
FUTREX-5000 (K922600)Futrex, Inc.1995-12-28
FUTREX-5000A (K922601)Futrex, Inc.1995-12-28
NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE (K942977)Novoste Corp.1995-12-28
DF-1 TERMINAL CAP (K954551)Pacesetter, Inc.1995-12-26
TRANSPORT CART (K952576)Belmont Instrument Corp.1995-12-26
Multi Side Hole lnfusion System (K953384)AngioDynamics, Inc.1995-12-22
ROTABLATOR ROTATIONAL ANGIOPLASTY (K953997)Heart Technology Mfg., Inc.1995-12-22
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS (K943896)Datascope Corp.1995-12-22
TRANSIT INFUSION CATHETER WITH SIDEHOLES (K954949)Cordis Neurovascular, Inc.1995-12-22
CORDIS WESTER STAR CATHETER (K954390)Cordis Webster, Inc.1995-12-21
CARTO SYSTEM (K954395)Biosense, Ltd.1995-12-21
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
VASCUTEK GELWEAVE VASCULAR GRAFT (K952293)Vascutek, Ltd.1995-12-19
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (K953866)Medtronic Vascular1995-12-15
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (K954092)Medtronic Vascular1995-12-15
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494 (K954809)Medtronic Vascular1995-12-13
THE NINER NITINOL GUIDEWIRE (K952860)Microvena Corp.1995-12-13
DISPOSABLE ECG MONITORING ELECTRODE (K950473)Nikomed U.S.A., Inc.1995-12-12
ACS TOURGIDE GUIDING CATHETER (K953987)Advanced Cardiovascular Systems, Inc.1995-12-07
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) (K954582)C.R. Bard, Inc.1995-12-07
LIFE SOUND SENSOR AMPLIFIER-LISA (K953833)Flowscan, Inc.1995-12-05
FOCUS PC BALLOON DILATATION CATHETER (K954313)Cardio-Dynamics, Inc.1995-12-01
ANGIOPTIC ANGIOGRAPHIC CATHETER (K954423)AngioDynamics, Inc.1995-12-01
DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM (K953651)Arrow Intl., Inc.1995-11-30
9267 SPO2 ATHENA MODULE (K940933)S & W Medico Teknik1995-11-29
CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (K952184)Carbomedics, Inc.1995-11-29
GLADIATOR ANTISHOCK PANTS (K953763)Jobst Institute, Inc.1995-11-28
DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS (K954317)Daig Corp.1995-11-28
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] (K951566)Baxter Healthcare Corp1995-11-27
NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM (K945944)Nihon Kohden America, Inc.1995-11-27
RADIFOCUS INTRODUCER II KIT (K954234)Terumo Medical Corp.1995-11-27
BODYSTAY (K951097)Bodystat , Ltd.1995-11-22
NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER (K946175)Nihon Kohden America, Inc.1995-11-22
CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER (K953768)Cordis Webster, Inc.1995-11-22
ARISTO MEDICAL MODEL 2101 PATIENT MONITOR (K953817)Aristo Medical Products, Inc.1995-11-22
MEDTRONIC GC IV CORONARY GUIDING CATHETER (K950490)Medtronics Interventional Vascular1995-11-21
CAD-2000 CARDIAC ASSIST DEVICE (K951124)Eee Medical Ent.1995-11-20
OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS (K945138)Invivo Research, Inc.1995-11-20
K-DEFIB/PACE PEDIATRIC ELECTRODE (K954504)Katecho, Inc.1995-11-17
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM (K950739)3M Health Care, Sarns1995-11-17
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER (K954391)Bio-Tek Instruments, Inc.1995-11-17
ENTERPRISE (K935998)Camp Intl., Inc.1995-11-17
DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 (K950475)Nikomed U.S.A., Inc.1995-11-14
DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM (K950472)Nikomed U.S.A., Inc.1995-11-14
XXL BALLON DILATATION CATHETER (K952063)Boston Scientific Corp1995-11-14
NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER (K945578)Nihon Kohden America, Inc.1995-11-14
SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER (K953909)Scimed1995-11-13
HEARTHWATCH III(TM) (K945476)Instromedix, Inc.1995-11-09
MODELS 5866-45 AND 5866-46 SIZING SLEEVE (K954085)Medtronic Vascular1995-11-07
MIKRO-TIP ANGIOGRAPHIC CATHETER (K952773)Millar Instruments, Inc.1995-11-07
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) (K954913)Cardio Metrics, Inc.1995-11-07
EDM (K951369)Deltex Medical1995-11-07
CORDIS WIZDOM STEERABLE GUIDEWIRE (K953760)Cordis Corp.1995-11-07
DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM (K950480)Nikomed U.S.A., Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM (K950471)Nikomed U.S.A., Inc.1995-11-06
DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM (K950477)Nikomed U.S.A., Inc.1995-11-06
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