meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
1985-12-17

Clearances · page 160 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854752 THE CALIFORNIA SPLINT Intl. Medication Systems, Ltd. DXQ Class II 1985-12-17
K854045 MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED American Bentley DTZ Class II 1985-12-16
K853950 ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL American Bentley DTL Class II 1985-12-11
K853673 CARDIORATER CR 51 Cardiac Recorders, Ltd. DRT Class II 1985-12-11
K853987 PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE Pall Biomedical Products Co. DTM Class II 1985-12-11
K840367 PRESSURE TRIGGER MOD OF SMEC INTRA-AORT Smec, Inc. DSP Class II 1985-12-11
K853072 CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90 Camino Laboratories, Inc. DYB Class II 1985-12-09
K853725 ATRIUM PLASMA TFE SYNTHETIC ARTERY Atrium Medical Corp. DSY Class II 1985-12-09
K853732 LIFEPAK 8 MODIFICATION Physio-Control Corp. DRO Class II 1985-12-09
K854069 POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD Intermedics, Inc. DTB Class III 1985-12-09
K852892 MEDILOG M6 Oxford Medilog, Inc. DSI Class II 1985-12-09
K853791 NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 Norton Performance Plastics Corp. DTR Class II 1985-12-09
K853398 MEDTRONIC MODEL 5062 Medtronic Vascular DTB Class III 1985-12-04
K853850 EXPLORER Mansfield Scientific, Inc. DTB Class III 1985-12-04
K854307 KONTRON DEFIBRILLATOR 7501 Kontron Instruments, Inc. LDD Class II 1985-12-04
K854220 PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD Pacesetter Systems DTB Class III 1985-12-04
K854071 POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD Intermedics, Inc. DTB Class III 1985-12-04
K853521 POLYFLEX IMPLANTABLE PACING LEAD-476-07 Intermedics, Inc. DTB Class III 1985-12-04
K852710 IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A Telectronics, Inc. DTB Class III 1985-12-04
K854136 ARRHYTHMIA REVIEW STATION Marquette Electronics, Inc. DXG Class II 1985-12-04
K852654 CARDIAC COMMUNICATOR 2000 Creative Medical, Inc. DSI Class II 1985-12-04
K853294 CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA Cardiac Control Systems, Inc. DTB Class III 1985-12-04
K854310 ACS INDEFLATOR (MODIFICATION) Advanced Cardiovascular Systems, Inc. DXT Class II 1985-12-04
K854405 PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD Pacesetter Systems DTB Class III 1985-12-04
K854261 ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES Advanced Cardiovascular Systems, Inc. DTL Class II 1985-12-04
K853517 LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08 Intermedics, Inc. DTB Class III 1985-12-04
K853383 CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN Webster Laboratories, Inc. DYG Class II 1985-12-03
K853914 PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI Pacesetter Systems DTB Class III 1985-12-03
K854132 COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS Cook Pacemaker Corp. DXY Class III 1985-12-03
K854214 MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE Cordis Corp. DXY Class III 1985-12-03
K853099 L.O.N. PRES MON LINES, CPC LINES, ADMINISTRATION L.O.N. Research, Inc. DTL Class II 1985-12-03
K854137 ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC Arrow Intl., Inc. DQY Class II 1985-12-03
K851365 SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM Sorin Biomedica, Fiat, USA, Inc. DXY Class III 1985-12-03
K853136 MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER) E.A. Fischione Instrument Mfg. MAV Class II 1985-12-03
K854273 SILICONE OIL 350 CNETISTOKE Pacific Medical Industries KRD Class II 1985-11-22
K851625 SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 Eaton Medical Group DSF Class I 1985-11-19
K852910 CARDIORATER CR7 Cardiac Recorders, Ltd. DRT Class II 1985-11-19
K852652 OMNIGRAPH 4000(ELECTROCARDIOGRAPH) Telemed Div. DRS Class II 1985-11-19
K852795 SUNBEAM HEALTH MONITOR MODEL NO. 7600 Aanson Scale Co. DXN Class II 1985-11-18
K853260 OMRON DIGITAL BP MONITOR HEM-700C Omron Tateisi Electronics Co. DXN Class II 1985-11-18
K840574 EBM-500 Bosch Hearing Instruments, Inc. DXN Class II 1985-11-14
K853503 SHILEY 3L CARDIOTOMY RESERVOIR Shiley, Inc. DTP Class II 1985-11-14
K853158 DIGITAL SPHYGMOMANOMETER MODEL 7620 Takeda Medical, Inc. DXN Class II 1985-11-14
K851662 LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR Logos Medical Co., Ltd. DPS Class II 1985-11-14
K853516 SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM 3M Health Care, Sarns DTR Class II 1985-11-14
K852887 CR5 CARDIAC MONITOR Cardiac Recorders, Ltd. DRT Class II 1985-11-14
K852968 PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM Personal Computers For Medicine, Inc. DSI Class II 1985-11-14
K853586 PRESSURE SENSING SYRINGE 65000 Dlp, Inc. DTL Class II 1985-11-14
K853352 FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR Fukuda Denshi USA, Inc. DSI Class II 1985-11-14
K852340 SUPRIMA MODEL 254-24 Intermedics, Inc. DXY Class III 1985-11-08
K851627 KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR Eaton Medical Group DRW Class II 1985-11-08
K852339 SUPRIMA MODEL 254-22 Intermedics, Inc. DXY Class III 1985-11-08
K841960 CARDIO METRICS INVASIVE PRESSURE MONIT Sterile Design, Inc. DRS Class II 1985-11-08
K851632 PCX-100 PATIENT INPUT LEADWIRE Eaton Medical Group DRW Class II 1985-11-08
K852197 LAP-CATH Research Medical, Inc. DQO Class II 1985-11-06
K853124 NOVAMETRIX PULSE OXIMETER, MODEL 500 Novametrix Medical Systems, Inc. JOM Class II 1985-11-06
K853985 MVM 4000 HOLTER IV RECORDER Mountain View Medical DSH Class II 1985-11-06
K853998 GUIDING CATHETER Target Therapeutics DQY Class II 1985-11-06
K853209 COMPAS 1 Cardiac Care Units, Inc. DSI Class II 1985-11-05
K852905 CR 280/45, CR281/4 DEFIBRILLATOR Cardiac Recorders, Ltd. LDD Class II 1985-11-05
K850812 EMERGIPACE - EXTERNAL PACEMAKER Life Science Instrumentation, Inc. DRO Class II 1985-11-05
K853999 GUIDE WIRE Target Therapeutics DQX Class II 1985-11-05
K852791 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS Cardio-Vascular Innovations, Inc. DQY Class II 1985-11-05
K853518 LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06 Intermedics, Inc. DTB Class III 1985-11-05
K853997 INFUSION CATHETER Target Therapeutics DQY Class II 1985-11-05
K854000 INFUSION CATHETER W/SIDE HOLES Target Therapeutics DQY Class II 1985-11-05
K852748 CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK Cordis Corp. DXY Class III 1985-11-01
K852688 MEDTRONICS MODELS 8320/8322/8329 Medtronic Vascular DXY Class III 1985-11-01
K852456 FAP-CATH Research Medical, Inc. DQO Class II 1985-11-01
K852097 PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM Medi-Tech, Inc. DTK Class II 1985-11-01
K854143 BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS Telectronics, Inc. DXY Class III 1985-11-01
K853313 DUROMEDICS CARDIAC VALVE SIZER SET Hemex Scientific, Inc. DTI Class I 1985-11-01
K853769 IRREGULAR CURVE TRACING REVISITION & DOPPLER Hewlett-Packard Co. DXK Class II 1985-10-31
K853138 MILLAR MIKRO-TIP DOPPLER CATHETER Millar Instruments, Inc. JOP Class II 1985-10-29
K853519 LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03 Intermedics, Inc. DTB Class III 1985-10-24
K851522 DIAGNOSTIC ECG DISPOSABLE ELECTRODE Sentry Medical Products, Inc. DRX Class II 1985-10-24
K851901 750 SD ULTRASOUND SCANNER(MODIFICATION) Ultrasonix, Inc. DXK Class II 1985-10-23
K850165 MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 Hoffrel Instruments, Inc. JOP Class II 1985-10-23
K853590 COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI Cook Pacemaker Corp. DXY Class III 1985-10-23
K853651 COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER Cook Pacemaker Corp. DXY Class III 1985-10-23
K852971 #9431 TELETRACE, TELEPHONE, EKG TRANSMITTER Medtronic Vascular DXH Class II 1985-10-22
K852407 SENSOR TAPE CAT. NO. ST-45 American Omni Medical, Inc. DTW Class II 1985-10-21
K853746 ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO Advanced Cardiovascular Systems, Inc. LIT Class II 1985-10-21
K853860 REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE Quinton, Inc. DQY Class II 1985-10-18
K851486 GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX Gould, Inc. DRS Class II 1985-10-17
K853128 SARNS EVACUPLEGE CATHETER 3M Health Care, Sarns DWF Class II 1985-10-17
K853251 J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO Johnson & Johnson Professionals, Inc. DTZ Class II 1985-10-16
K853126 BIO PACK MODEL 200 Bio Medicus, Inc. DWA Class II 1985-10-11
K852984 SHILEY CSD EXTENSION LINE WITH FILTER Shiley, Inc. DWF Class II 1985-10-11
K853439 MODEL 43130A DEFIBRILLATOR Hewlett-Packard Co. LDD Class II 1985-10-11
K853354 MEDIC 4 Kone Instruments, Inc. LDD Class II 1985-10-11
K852958 PACEPAC Medical Data Electronics DRO Class II 1985-10-11
K852238 IPG-300 Thornton Associates, Inc. DSB Class II 1985-10-11
K853564 LIFEPAK 200 Physio-Control Corp. MKJ Class III 1985-10-11
K853213 FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON Fukuda Denshi USA, Inc. DSI Class II 1985-10-11
K853080 WILLIAM HARVEY HYBID OXYGENATOR H-1700 C.R. Bard, Inc. DTZ Class II 1985-10-11
K853262 CARDIO DATA PACERECORDER PR3 Cardio Data DSH Class II 1985-10-11
K853410 MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. DTR Class II 1985-10-11
K852872 ANGIOMEDICS SOFTIP CATHETER Angiomedics, Inc. DQO Class II 1985-10-11
K853818 MEDTRONIC MODEL 6405 Medtronic Vascular LDF Class II 1985-10-11

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