meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
1981-12-29

Clearances · page 177 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K813514 EDSLAB CATHETER COVER American Edwards Laboratories DQY Class II 1981-12-29
K813499 OMED DISPOSABLE BULLDOG Omega-Med Intl., Inc. DXC Class II 1981-12-29
K813323 THIGH CUFF: X-LARGE CUFF Abco Dealers, Inc. DXQ Class II 1981-12-29
K813284 VENOUS CANNULA TRAY Cunningham Woodland, Inc. DWS Class I 1981-12-29
K812586 KANTRON 504 HEARTSTATION Kantron Cardiovascular, Inc. LDD Class II 1981-12-29
K812739 VITALOG PMS-8 MONITOR Vitalog Corp. DQK Class II 1981-12-29
K813461 PERCUTANEOUS ENTRY NEEDLE, SELDINGER Ocean Medical Products, Ltd. DRE Class II 1981-12-29
K813222 MODEL 4200 ELLESTAD STRESS TEST ANALYZER Del Mar Avionics DXG Class II 1981-12-29
K813358 GERARD MEDICAL ELECTRODE TESTER Gerard Medical Enterprises, Inc. KRC Class II 1981-12-29
K812914 MICRO-PREPROCESSOR UNIT General Electric Co. DSI Class II 1981-12-29
K812955 EAST WATER UNIT MARK 3 Cairco , Ltd. DWJ Class II 1981-12-29
K812971 CARDIOINTEGRAM Ocg Technology, Inc. DXG Class II 1981-12-29
K812659 TERUMO HOLLOW OXYGENATOR CIRCUIT Terumo Medical Corp. DTM Class II 1981-12-14
K813279 ELECTROCARDIOGRAPH CM3000 Philips Medical Systems (Cleveland), Inc. DPS Class II 1981-12-14
K813037 FLOWGUARD CATHETERS & CANNALAE Advocacy International, Ltd. DWF Class II 1981-12-14
K813062 VASCULAR PAWS Sil-Med Corp. DXC Class II 1981-12-14
K813125 MICRO TRANSDUCER CATHETERS Honeywell, Inc. DRE Class II 1981-12-14
K813287 CC-201 ECG MONITORING SYSTEMS Anthro-Metrics Corp. DSI Class II 1981-12-14
K813267 DISPOSABLE DIAPHRAGM DOMES Dio-Med Corp. DRS Class II 1981-12-14
K812660 TERUMO HOLLOW FIBER OXYGENATOR Terumo Medical Corp. DTZ Class II 1981-12-14
K813021 FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36 Brentwood Instruments, Inc. DPS Class II 1981-12-14
K812936 BLOOD PRESSURE MONITOR Amertek DXN Class II 1981-12-14
K813020 BOMED-NCCOM Bomed Medical Mfr., Ltd. DXG Class II 1981-12-14
K813028 POLY-FLEX PACING LEADS Intermedics, Inc. DTB Class III 1981-12-10
K813138 ETHICON* TEMP. CARDIAC PACING WIRE ETHICON, Inc. LDF Class II 1981-12-10
K813134 ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP Telectronics, Inc. DTB Class III 1981-12-10
K812610 SIEMENS-ELEMA PULSE GENERATOR 668 B Siemens Corp. DXY Class III 1981-12-10
K813079 BIPOLAR OPTIMA MP #255 Telectronics, Inc. DXY Class III 1981-12-10
K813276 IONESCU-SHILEY VALVE HOLDER & HANDLE Shiley, Inc. DTJ Class I 1981-12-10
K813137 CORREC TORR TM Norton Performance Plastics Corp. DRS Class II 1981-12-02
K812104 SIEMENS-ELEMA PSA 376 Siemens Corp. DTA Class II 1981-12-02
K813153 TEST MAGNET Pacesetter Systems DTG Class I 1981-12-02
K813023 FUKUDA DENSHI CARDIMAX FK-11 Brentwood Instruments, Inc. DSP Class II 1981-12-02
K812408 L.O.N. DISPOSABLE CORONARY MANIFOLD L.O.N. Research, Inc. DTL Class II 1981-12-02
K812932 ANERIOD GAUZE Abco Dealers, Inc. DXG Class II 1981-12-02
K812920 EVENT MASTER Instruments For Cardiac Research DSH Class II 1981-12-02
K813150 DIRECTIONAL BOOT Pacesetter Systems DXY Class III 1981-12-02
K812407 L.O.N. REUSABLE MANIFOLDS & STOPCOCKS L.O.N. Research, Inc. DTL Class II 1981-12-02
K813152 ELECTRODE TERMINAL CAP Pacesetter Systems DTD Class II 1981-12-02
K813154 ADAPTING SLEEVE Pacesetter Systems DTD Class II 1981-12-02
K813151 VITATRON INSERT Pacesetter Systems DTD Class II 1981-12-02
K813022 FUKUDA DENSHI CARDIMAX FK-12 Brentwood Instruments, Inc. DPS Class II 1981-12-02
K813034 POLYSTAN HEART LUNG MACHINE SYS Advocacy International, Ltd. DTQ Class II 1981-11-27
K813140 VYGON EXTENSION TUBES & CONNECTORS Exco, Inc. DQO Class II 1981-11-27
K810286 PACEPATH IMPLANT. ENDOCARD. PACING LEAD Pacesetter Systems DTB Class III 1981-11-27
K813101 CARDIOBEEPER MEMORY MONITOR Survival Technology, Inc. DXY Class III 1981-11-27
K813143 DESILET Exco, Inc. DYB Class II 1981-11-27
K810139 ELECTRODE, PACEMAKER, PERMANENT Pacesetter Systems DTB Class III 1981-11-27
K813144 INTRAFLON, INTRAFLUX, INTRAVALVE Exco, Inc. DQR Class II 1981-11-27
K813131 INTERFACE ARTERIAL BLOOD FILTER Medical, Inc. DTM Class II 1981-11-27
K813123 EPC FILTER Codman & Shurtleff, Inc. DRR Class II 1981-11-27
K813142 LEADER-CATH Exco, Inc. DQO Class II 1981-11-27
K813035 POLYSTAN VERTICLUDE BLOOD PUMP Advocacy International, Ltd. DWB Class II 1981-11-27
K813141 VYGON STOPCOCKS & RAMPS(MANIFOLDS) Exco, Inc. DTL Class II 1981-11-27
K813013 GEL ELECTRODE Arndt Automation & Assoc. DRX Class II 1981-11-27
K812248 COOLEY 2 VASCULAR PROSTHESIS STRAIGHT Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1981-11-24
K812990 INTERMEDICS POLYFLEX-MODEL 483-03 LEAD Intermedics, Inc. DTB Class III 1981-11-16
K812991 INTERMEDICS POLYFLEX-MODEL 483-04 LEAD Intermedics, Inc. DTB Class III 1981-11-16
K812935 FOGARTY FLEXIBLE PROBE American Edwards Laboratories DWP Class II 1981-11-16
K812755 MODEL 535-03 TRACE A PACE Intermedics, Inc. DXH Class II 1981-11-16
K812989 INTERMEDICS POLYFLEX-MODEL 493-03 LEAD Intermedics, Inc. DTB Class III 1981-11-16
K813019 PERCUTANEOUS INTRODUCER: SELDINGER STYLE Dip, Inc. DYB Class II 1981-11-16
K812209 ULTRA COM Ultranamics, Inc. DXK Class II 1981-11-16
K812964 INTRODUCER, PERCUTANEOUS SELDINGER Triad Medical Division DYB Class II 1981-11-16
K812999 PET POLYETHYLENE TORQUE CATHETER Universal Medical Instrument Corp. DQO Class II 1981-11-16
K812725 MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD Medtronic Vascular LDF Class II 1981-11-16
K812646 SKI 5000 Smithkline Diagnostics, Inc. DXK Class II 1981-11-16
K812464 SYNTHEMED PULSE GENERATOR VVI MODEL 1000 Synthemed Corp. DXY Class III 1981-11-16
K813053 DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM Bentley Laboratories, Inc. DRS Class II 1981-11-16
K812944 MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. Millar Instruments, Inc. DRF Class II 1981-11-16
K812111 PRUITT ARTERIAL OCCLUSION CHOLANG. CATH Bionomy, Inc. DYG Class II 1981-11-16
K812973 PERCUTANEOUS INTRODUCER COURNAND STYLE Dip, Inc. DYB Class II 1981-11-16
K812638 DIAGNOSTIC MEDICAL COMPUTER Diagnostic Resources, Inc. DXG Class II 1981-11-16
K812828 MODEL 2000 MONITOR Datascope Corp. DRT Class II 1981-11-16
K812946 TRONZO HIP Biomet, Inc. DXQ Class II 1981-11-06
K812832 MODEL 325C UNIPOLAR CARDIAC PULSE GEN. Cook Pacemaker Corp. DXY Class III 1981-11-05
K812742 SHILEY ARTERIAL FILTER W/40 MICRON SCREE Shiley, Inc. DTM Class II 1981-11-02
K812757 SORENSON THERMODILUTION CARDIAC COMPUT Sorensen Research DXG Class II 1981-11-02
K812884 NARCO TELECARE PRESSURE TRANSDUCER DOME Narco Scientific DRS Class II 1981-11-02
K812878 THE NEW 1600 ELECTRODE Andover Medical, Inc. DRX Class II 1981-11-02
K812409 SPHYGMOMANOMETER Somatronix Research Corp. DXN Class II 1981-11-02
K812883 TELECARE ISOTEC PRESSURE TRANSDUCER DOME Narco Scientific DRS Class II 1981-11-02
K812761 FLOW-DIRECTED BALLOON THERMODILUTION Nova Medical Specialties KRG Class III 1981-11-02
K812790 IMPLANTABLE VENTRICULAR-INHIBITED CARDI Telectronics, Inc. DXY Class III 1981-10-29
K812815 MODEL 833 ENDOCARDIAL TINED LEAD Pacesetter Systems DTB Class III 1981-10-29
K812816 MODEL 841 ENDOCARDIAL TINED LEAD Pacesetter Systems DTB Class III 1981-10-29
K812781 TEMPORARY PERVENOUS J-ATRIAL LEAD Cordis Corp. LDF Class II 1981-10-29
K812756 ADAPTAID #365-38 Intermedics, Inc. DTD Class II 1981-10-29
K812358 MODEL 325T PROGRAMMABLE PULSE GENERATOR Cook Pacemaker Corp. DXY Class III 1981-10-29
K812813 INTERMEDICS PROGRAMMER, MODEL 522-03 Intermedics, Inc. KRG Class III 1981-10-27
K812812 INTERMEDICS ADAPTAID STEP-DOWN ADAPTER Intermedics, Inc. DTD Class II 1981-10-27
K812599 MEDTRONIC #4951 Medtronic Vascular DTB Class III 1981-10-23
K812564 ZEE LIFE SUPPORT AIR PANTS Zee Medical Products Co., Inc. LHX Class II 1981-10-23
K812455 SUCKER CARDIOTOMY RETURN, C.P. BYPASS Electromedics, Inc. DTN Class II 1981-10-23
K812703 MODEL 9408 A TELETRACE Medtronic Vascular DXH Class II 1981-10-23
K812758 PHYSIOLOGICAL PRESSURE TRANSDUCER Electromedics, Inc. DRS Class II 1981-10-20
K812800 FLOW-DIRECTED THERMODILUTION CATHETER Sorensen Research KRB Class II 1981-10-20
K812763 ECG MEDATAPE-601 Hospital Equipment Service DSH Class II 1981-10-20
K810338 LYMPHA PRESS Mego Afek JOW Class II 1981-10-20
K812304 DORROS-SPRING PRESSURIZER Cardiovascular Diagnostic Services MAV Class II 1981-10-13

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