meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
36
Latest Decision
1985-05-16

Clearances · page 163 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850867 ACCUTRACKER HEART-RATE MONITOR Eutectic Electronics, Inc. DXN Class II 1985-05-16
K844840 DESERET INTRODUCER SET Parke-Davis Co. DYB Class II 1985-05-16
K851322 PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH Parexel Intl. Corp. DPS Class II 1985-05-16
K851049 NORELCO BLOOD PRESSURE METER Philips Park DXN Class II 1985-05-16
K850135 MEDWATCH 400 CARDIAC CENTRAL NURSES STATION Medwatch Systems, Inc. DRT Class II 1985-05-16
K851035 AMERICAN BENTLEY OXYGENATOR MAX-2 American Bentley DTZ Class II 1985-05-16
K842435 MODEL T 101 CLINICAL TRANSMITTER Biometric Products, Inc. DXH Class II 1985-05-16
K850322 RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPH Eaton Medical Group DPS Class II 1985-05-16
K844800 OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS Vas-Cath of Canada , Ltd. DQO Class II 1985-05-16
K844972 ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER Advanced Cardiovascular Systems, Inc. LIT Class II 1985-05-16
K840522 RECOMED BLOOD-FLOW METER H236-052-02 Litton Medical Electronics DPW Class II 1985-05-16
K851861 PROGRAMALITH III MODEL 249 PULSE GENERATOR Pacesetter Systems DXY Class III 1985-05-16
K850323 TELEMETRY SOFTWARE FOR G-2000 ELECTROCARDIOGRAPH Eaton Medical Group DPS Class II 1985-05-16
K850893 BP/CLINIC SYS MEASUREMENT, BP NON-INVASIVE Sun Dance Technology, Inc. DXN Class II 1985-05-16
K844731 KONTRON SUPERMON 7210 PATIENT MONITOR Kontron Instruments, Inc. DRT Class II 1985-05-16
K851102 VASOSCREEN IMPEDANCE PLETHYSMOGRAPH Sonicaid, Inc. DQB Class II 1985-05-16
K843390 COPAL DIGITAL SPHYGMOMANOMETER UA-535 Takeda Medical, Inc. DXN Class II 1985-05-15
K851139 THUMPER CARDIOPULMONARY RESUSCITATOR 1005 Michigan Instruments, Inc. DRM Class II 1985-05-15
K851274 OHMEDA MODEL 0001/0003 RECORDER Ohmeda Medical DSF Class I 1985-05-15
K845051 VITALOG PMS-8 Vitalog Corp. DPZ Class II 1985-05-15
K851124 T-1000 ECG TRANSMITTER Brentwood Instruments, Inc. DXH Class II 1985-05-15
K851302 QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR Quinton, Inc. DRG Class II 1985-05-15
K843446 DIGITAL SPHYGMOMANOMETER BP-2500 Pollenex Associated Mills, Inc. DXN Class II 1985-05-15
K851123 R-1000 ECG RECEIVER Brentwood Instruments, Inc. DXH Class II 1985-05-15
K850464 PROGRAMALITH III 240 PULSE GENERATOR Pacesetter Systems DXY Class III 1985-05-15
K844969 CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) Cordis Corp. DTC Class II 1985-05-01
K844803 POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE Electromedics, Inc. DTP Class II 1985-04-29
K850476 NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-1050 Unisonic Products Corp. DXN Class II 1985-04-29
K850477 NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-2050 Unisonic Products Corp. DXN Class II 1985-04-29
K850385 INTRACARDIAC SUMP 12010 Dlp, Inc. DWF Class II 1985-04-29
K850879 HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR Mennen Medical, Inc. DSK Class II 1985-04-25
K850880 HORIZON 1000 CARDIAC MONITOR Mennen Medical, Inc. DRT Class II 1985-04-25
K850702 CARDIOVIT CS-6 ECG-RECORDER Schiller AG DPS Class II 1985-04-25
K850394 LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR Vascutech, Inc. DWS Class I 1985-04-24
K844483 TP 1 Vitatron Medical BV KRG Class III 1985-04-19
K850618 FC-700 DEFIBRILLATOR Fukuda Denshi USA, Inc. LDD Class II 1985-04-19
K851246 NUMED BALLOON PACING CATHETER NuMED, Inc. LDF Class II 1985-04-19
K850623 OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE Oscor Medical Corp. DTB Class III 1985-04-19
K844485 CERYX6, 611, CERYX 3 311 & CERYX 1 111 Vitatron Medical BV KRG Class III 1985-04-19
K851078 HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER Hdc Corp. DYB Class II 1985-04-19
K851247 AMENDMENT LIFEPAK 200, NPN 046 Physio-Control Corp. DRO Class II 1985-04-19
K851145 PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD Pacesetter Systems DTD Class II 1985-04-19
K851248 AMENDMENT LIFEPAK 100, NPN 045 Physio-Control Corp. DRO Class II 1985-04-19
K844396 POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 Associated Mills, Inc. DSK Class II 1985-04-18
K844397 POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 Associated Mills, Inc. DSK Class II 1985-04-18
K844285 COPAL DIGITAL SPHYGMOMAMOMETER UA-550 Takeda Medical, Inc. DXN Class II 1985-04-18
K850407 NEONATAL MONITOR 309 Rigel Medical Electronics, Inc. DRT Class II 1985-04-18
K844795 NEOS-M PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1985-04-18
K844310 BLOOD-PRESSURE ECG TRANSMITTER Instromedix, Inc. DXN Class II 1985-04-18
K844794 LEPTOS PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1985-04-18
K844842 NEOS-LP PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1985-04-18
K850343 DISPLAY MONITOR (VD-711RA-VD-712RA) Nihon Kohden America, Inc. DXJ Class II 1985-04-18
K850166 TELEMANOMETER R.J. Ash, Medical Monitoring, Inc. DRG Class II 1985-04-18
K844841 KALOS-04 PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1985-04-18
K850794 PATIENT MONITOR MODEL RM-300 Honeywell, Inc. DTR Class II 1985-04-18
K844812 NEOS - PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1985-04-18
K850318 UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-4050 Nihon Seimitsu Sokki Co., Ltd. DXN Class II 1985-04-18
K850315 UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050 Nihon Seimitsu Sokki Co., Ltd. DXN Class II 1985-04-16
K850317 UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050 Nihon Seimitsu Sokki Co., Ltd. DXN Class II 1985-04-16
K850316 UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 Nihon Seimitsu Sokki Co., Ltd. DXN Class II 1985-04-16
K851091 MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR Medtronic Vascular JOQ Class II 1985-04-16
K844187 SIEMENS SIRECUST 404N NEONATAL MONITOR Siemens Medical Solutions USA, Inc. DRT Class II 1985-04-11
K851296 IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH Telectronics, Inc. DTB Class III 1985-04-11
K844392 CARDIOSTAT 1 ECG RECORDER Siemens Elema AB DPS Class II 1985-04-11
K850065 ELECATH TORKFLOAT PACING PROBE Electro-Catheter Corp. DTB Class III 1985-04-10
K851092 PORTABLE DEFIBRILLATOR/MONITOR ED 425 Honeywell, Inc. LDD Class II 1985-04-10
K850652 PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD Pacesetter Systems DTD Class II 1985-04-10
K850353 CORONARY INFUSION CATHETER W/SIDEHOLES Advanced Cardiovascular Systems, Inc. DQY Class II 1985-04-10
K850760 MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER Scimed Life Systems, Inc. LIT Class II 1985-04-10
K851297 IMPLANTABLE ELECTRODE LEAD, 030-270 USING POLYURET Telectronics, Inc. DTB Class III 1985-04-10
K850139 COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER Rapid Diagnostic Laboratories, Inc. KRJ Class II 1985-04-10
K850622 OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR Oscor Medical Corp. LDF Class II 1985-04-10
K850216 CARDIAC SECTOR PROBE 5.0 MHZ Siemens Medical Solutions USA, Inc. JOP Class II 1985-04-10
K850075 SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT Scimed Life Systems, Inc. LIT Class II 1985-04-10
K851294 IMPLANTABLE ELECTRODE LEAD 030-272 USING POLYURETH Telectronics, Inc. DTB Class III 1985-04-10
K851295 IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH Telectronics, Inc. DTB Class III 1985-04-10
K842539 DIAGNOSTIC ULTRASOUND 105 & 110 Diagnostic Ultrasound Corp. JOP Class II 1985-04-10
K843058 Q-DOP Quinton, Inc. JOP Class II 1985-04-10
K850897 FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES Fukuda Denshi USA, Inc. DSI Class II 1985-04-10
K844791 SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A Analogic Corp. DSI Class II 1985-04-10
K850820 PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID Universal Medical Instrument Corp. DYB Class II 1985-04-10
K850145 CARDIAC SECTOR PROBE 3.5. MHZ Siemens Medical Solutions USA, Inc. JOP Class II 1985-04-10
K850365 RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE Eaton Medical Group DSF Class I 1985-04-09
K844101 CARDIO-NEC MODEL 365 Birtcher Corp. DPS Class II 1985-04-09
K850568 MODEL 78231D CARDIAC OUTPUT MODULE Hewlett-Packard Co. DXG Class II 1985-04-09
K844997 IAI PROGRAM-COMPUTER PROGRAM Intl. Acoustics, Inc. DXG Class II 1985-04-09
K850132 DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC Consolidated Medical Equipment, Inc. DRX Class II 1985-04-09
K850130 PRN ECG ELECTRODE Consolidated Medical Equipment, Inc. DRX Class II 1985-04-09
K844988 ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. Ethox Corp. DXQ Class II 1985-04-04
K844215 KONTRON MINIMON 7134 PATIENT MONITOR Kontron Instruments, Inc. DRT Class II 1985-04-04
K851081 IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II Telectronics, Inc. DXY Class III 1985-04-04
K850252 QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR Telectronics, Inc. DXY Class III 1985-04-04
K845045 VENOUS RETURN CATHETER SS-1 Dlp, Inc. DWF Class II 1985-04-03
K845046 PUL,MONARY ARTERY VENT CATHETER Dlp, Inc. DWF Class II 1985-04-03
K850271 ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR Angiomedics, Inc. DQO Class II 1985-04-03
K844464 PROGRAMMABLE PATIENT SIMULATOR Ramford Labs DSI Class II 1985-04-03
K802294 POLY FLEX IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1985-04-03
K813136 MODEL 492-01 PACEMAKER LEAD Intermedics, Inc. DTB Class III 1985-04-03
K820267 INTERMEDICS POLYFLEX PACING LEAD #480-01 Intermedics, Inc. DTB Class III 1985-04-03
K813135 MODEL 486-01 PACEMAKER LEAD Intermedics, Inc. DTB Class III 1985-04-03

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