meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
1996-01-29

Clearances · page 118 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K952984 MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F) Map Medical Equipment, Inc. DQO Class II 1996-01-29
K945068 OMEGA CARES SYSTEM J-F Medical Systems Intl., Inc. DQK Class II 1996-01-25
K955651 MEDTRONIC SHERPA GUIDING CATHETER Medtronics Interventional Vascular DQY Class II 1996-01-22
K950990 STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE Stoeckert Instrumente DTQ Class II 1996-01-19
K954604 ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY Heart Technology Mfg., Inc. MCW Class II 1996-01-18
K952329 LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM Progressive Dynamics, Inc. DWJ Class II 1996-01-17
K951096 LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER Instromedix, Inc. DXH Class II 1996-01-16
K952065 PACEART CARDIOVOICE Paceart, Inc. DXH Class II 1996-01-16
K954501 BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM Medtronic Bio-Medicus, Inc. DTY Class II 1996-01-16
K953265 SCIMED ANGIOGRAPHIC KITS Scimed Life Systems, Inc. DQY Class II 1996-01-16
K952659 TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM Tronomed, Inc. DSA Class II 1996-01-11
K953204 PEDIATRIC QUIK-COMBO Physio-Control Corp. MKJ Class III 1996-01-11
K954431 PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS Boston Scientific Corp DSP Class II 1996-01-11
K955046 SOFT VENOUS RESERVOIR Gish Biomedical, Inc. DTN Class II 1996-01-11
K954609 HEARTSTART 911 Laerdal Medical Corp. MKJ Class III 1996-01-04
K950988 HOLTER 6000 Omega Medical Services, Inc. DQK Class II 1996-01-04
K954020 MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE Micro Therapeutics, Inc. KRA Class II 1996-01-02
K951593 LIFEPAK 11 Physio-Control Corp. DRO Class II 1995-12-29
K950856 ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 Zoll Medical Corp DRO Class II 1995-12-29
K922600 FUTREX-5000 Futrex, Inc. DSB Class II 1995-12-28
K942977 NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE Novoste Corp. DYB Class II 1995-12-28
K952494 DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR Nihon Seimitsu Sokki Co., Ltd. DXN Class II 1995-12-28
K922601 FUTREX-5000A Futrex, Inc. DSB Class II 1995-12-28
K954595 CORDIS BRITE TIP SHEATH INTRODUCER Cordis Corp. DYB Class II 1995-12-28
K952576 TRANSPORT CART Belmont Instrument Corp. DSP Class II 1995-12-26
K954551 DF-1 TERMINAL CAP Pacesetter, Inc. DTB Class III 1995-12-26
K954949 TRANSIT INFUSION CATHETER WITH SIDEHOLES Cordis Neurovascular, Inc. KRA Class II 1995-12-22
K943896 GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS Datascope Corp. DQX Class II 1995-12-22
K953997 ROTABLATOR ROTATIONAL ANGIOPLASTY Heart Technology Mfg., Inc. MCW Class II 1995-12-22
K953384 Multi Side Hole lnfusion System AngioDynamics, Inc. QEY Class II 1995-12-22
K954395 CARTO SYSTEM Biosense, Ltd. DQK Class II 1995-12-21
K954390 CORDIS WESTER STAR CATHETER Cordis Webster, Inc. DRF Class II 1995-12-21
K953608 NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. LIT Class II 1995-12-20
K953569 COURIER BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1995-12-20
K952293 VASCUTEK GELWEAVE VASCULAR GRAFT Vascutek, Ltd. DSY Class II 1995-12-19
K953866 MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) Medtronic Vascular DXY Class III 1995-12-15
K954092 ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) Medtronic Vascular DXY Class III 1995-12-15
K952860 THE NINER NITINOL GUIDEWIRE Microvena Corp. DQX Class II 1995-12-13
K954809 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494 Medtronic Vascular LDF Class II 1995-12-13
K950473 DISPOSABLE ECG MONITORING ELECTRODE Nikomed U.S.A., Inc. DRX Class II 1995-12-12
K954582 BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) C.R. Bard, Inc. DSY Class II 1995-12-07
K953987 ACS TOURGIDE GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1995-12-07
K953833 LIFE SOUND SENSOR AMPLIFIER-LISA Flowscan, Inc. DQD Class II 1995-12-05
K954313 FOCUS PC BALLOON DILATATION CATHETER Cardio-Dynamics, Inc. LIT Class II 1995-12-01
K954423 ANGIOPTIC ANGIOGRAPHIC CATHETER AngioDynamics, Inc. DQO Class II 1995-12-01
K953651 DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM Arrow Intl., Inc. DRF Class II 1995-11-30
K952184 CARBOMEDICS SUPRA-ANNULAR VALVE SIZER Carbomedics, Inc. DTI Class I 1995-11-29
K940933 9267 SPO2 ATHENA MODULE S & W Medico Teknik DQA Class II 1995-11-29
K953763 GLADIATOR ANTISHOCK PANTS Jobst Institute, Inc. LHX Class II 1995-11-28
K954317 DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS Daig Corp. DYB Class II 1995-11-28
K945944 NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM Nihon Kohden America, Inc. DSI Class II 1995-11-27
K951566 SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] Baxter Healthcare Corp DYG Class II 1995-11-27
K954234 RADIFOCUS INTRODUCER II KIT Terumo Medical Corp. DYB Class II 1995-11-27
K953768 CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER Cordis Webster, Inc. DRF Class II 1995-11-22
K953817 ARISTO MEDICAL MODEL 2101 PATIENT MONITOR Aristo Medical Products, Inc. DQA Class II 1995-11-22
K951097 BODYSTAY Bodystat , Ltd. DSB Class II 1995-11-22
K946175 NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER Nihon Kohden America, Inc. DRG Class II 1995-11-22
K950490 MEDTRONIC GC IV CORONARY GUIDING CATHETER Medtronics Interventional Vascular DQY Class II 1995-11-21
K951124 CAD-2000 CARDIAC ASSIST DEVICE Eee Medical Ent. DRM Class II 1995-11-20
K945138 OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS Invivo Research, Inc. DXN Class II 1995-11-20
K950739 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM 3M Health Care, Sarns DWA Class II 1995-11-17
K935998 ENTERPRISE Camp Intl., Inc. DQX Class II 1995-11-17
K954504 K-DEFIB/PACE PEDIATRIC ELECTRODE Katecho, Inc. MKJ Class III 1995-11-17
K954391 MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER Bio-Tek Instruments, Inc. DRL Class II 1995-11-17
K952063 XXL BALLON DILATATION CATHETER Boston Scientific Corp LIT Class II 1995-11-14
K950472 DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM Nikomed U.S.A., Inc. DRX Class II 1995-11-14
K945578 NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER Nihon Kohden America, Inc. DRG Class II 1995-11-14
K950475 DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 Nikomed U.S.A., Inc. DRX Class II 1995-11-14
K953909 SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER Scimed DQY Class II 1995-11-13
K945476 HEARTHWATCH III(TM) Instromedix, Inc. DXH Class II 1995-11-09
K952773 MIKRO-TIP ANGIOGRAPHIC CATHETER Millar Instruments, Inc. DQO Class II 1995-11-07
K953760 CORDIS WIZDOM STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1995-11-07
K954913 CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) Cardio Metrics, Inc. DQX Class II 1995-11-07
K954085 MODELS 5866-45 AND 5866-46 SIZING SLEEVE Medtronic Vascular DTB Class III 1995-11-07
K951369 EDM Deltex Medical DPW Class II 1995-11-07
K950480 DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM Nikomed U.S.A., Inc. DRX Class II 1995-11-06
K950471 DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM Nikomed U.S.A., Inc. DRX Class II 1995-11-06
K950470 DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM Nikomed U.S.A., Inc. DRX Class II 1995-11-06
K950478 DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM Nikomed U.S.A., Inc. DRX Class II 1995-11-06
K950474 DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM Nikomed U.S.A., Inc. DRX Class II 1995-11-06
K950477 DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM Nikomed U.S.A., Inc. DRX Class II 1995-11-06
K950436 WITT BIOMEDICAL SERIES IV Witt Biomedical Corporation MHX Class II 1995-11-02
K951247 SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS Baxter Healthcare Corp DTZ Class II 1995-11-02
K950003 CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS Instromedix, Inc. DXH Class II 1995-10-31
K951039 BLOOD PRESSURE CUFF 1 Pedia Pals, Inc. DXQ Class II 1995-10-31
K951041 BLOOD PRESSURE CUFF 3 Pedia Pals, Inc. DXQ Class II 1995-10-31
K951040 BLOOD PRESSURE CUFF 2 Pedia Pals, Inc. DXQ Class II 1995-10-31
K950760 ANALYST, MODEL DSP 300 Heart Sounds, Inc. DQD Class II 1995-10-31
K954066 MINISCOPE MS-3 Schiller America, Inc. DPS Class II 1995-10-27
K954669 FEMOSTOP, FEMOSTOP PUMP Radi Medical Systems AB DXC Class II 1995-10-27
K951683 A-V IMPULSE SYSTEM MODEL 6060 Novamedix , Ltd. JOW Class II 1995-10-26
K950004 HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER Aerotel, Ltd. DPS Class II 1995-10-24
K951977 DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883 Integrated Display Technology, Ltd. DXN Class II 1995-10-24
K954251 5F ENVOY GUIDING CATHETER (MODIFICATION) Cordis Neurovascular, Inc. DQY Class II 1995-10-23
K953472 NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR Nellcor, Inc. DXN Class II 1995-10-20
K952474 EAGLE 3000 PATIENT MONITOR Marquette Electronics, Inc. DRT Class II 1995-10-19
K953415 6200 VITAL SIGNS MONITOR Bci Intl., Inc. DPS Class II 1995-10-19
K953602 SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 1995-10-18
K953533 RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL Terumo Medical Corp. DQX Class II 1995-10-18
K950587 ECOTABS Msb , Ltd. DRX Class II 1995-10-16

19,212 clearances in the Cardiovascular panel. Data: openFDA.