meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
32
Latest Decision
1985-04-01

Clearances · page 164 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850651 PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR Pacesetter Systems DXY Class III 1985-04-01
K844839 DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX Critikon Company, LLC DXN Class II 1985-04-01
K844353 PHYSIOLOGICAL MONITOR 2100 Datascope Corp. DXN Class II 1985-04-01
K850487 NOVAMETRIX 350 RECORDER-PAPER CHART RECORDER Novametrix Medical Systems, Inc. DSF Class I 1985-03-29
K844272 MODEL 473-03 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K850494 OHMEDA BIOX 3700 PULSE OXIMETER Ohmeda Medical DPZ Class II 1985-03-28
K844267 MODEL 483-01 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844270 MODEL 480-01 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844269 MODEL 483-02 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844261 MODEL 490-01 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844268 MODEL 483-03 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844260 MODEL 476-03 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844265 MODEL 495-01 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844263 MODEL 493-01 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844259 MODEL 486-01 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844262 MODEL 483-01 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844264 MODEL 493-03 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844271 MODEL 479-01 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844266 MODEL 492-01 PACING LEAD Intermedics, Inc. DTB Class III 1985-03-28
K844733 KONTRON MINIMON 7131 PATIENT MONITOR Kontron Instruments, Inc. DRT Class II 1985-03-27
K844555 PATHFINDER CARDIOVASCULAR CATHETER Argon Medical Corp. DQO Class II 1985-03-27
K844970 CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS Cordis Corp. DTB Class III 1985-03-27
K850630 BLOOD OXYGENATOR MODEL NO. MAX-5 American Bentley DTZ Class II 1985-03-27
K850324 ELECATH OPEN TIP BIPOLAR PACING CATHETER Electro-Catheter Corp. LDF Class II 1985-03-27
K844732 KONTRON MINIMON 7132 PATIENT MONITOR Kontron Instruments, Inc. DRT Class II 1985-03-27
K842352 PRESSURE MONITORING KIT Utah Medical Products, Inc. DRS Class II 1985-03-25
K841788 UTAH DISPOSABLE PRESSURE TRANSDUCER Utah Medical Products, Inc. DRS Class II 1985-03-25
K850384 CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER Cardiac Control Systems, Inc. DXY Class III 1985-03-21
K843620 SCANHEADS-ACCESS 10PV, BIOSTATIC Advanced Technology Laboratories, Inc. JOP Class II 1985-03-12
K843953 SCANHEADS ACCESS 10 10PV B10 Advanced Technology Laboratories, Inc. JOP Class II 1985-03-12
K844901 AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH American Bentley DTZ Class II 1985-03-07
K844974 MEDTRONIC 5061 ENDOCARDIAL PACING LEAD Medtronic Vascular DTD Class II 1985-03-06
K844682 ELECATH CARDIAC OUTPUT COMPUTER Electro-Catheter Corp. DXG Class II 1985-03-06
K850596 PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & Cardiac Resucitator Corp. DRO Class II 1985-03-06
K844693 PEEL-AWAY INTRODUCER SET Quinton, Inc. DYB Class II 1985-03-06
K850576 PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR Pacesetter Systems DTD Class II 1985-03-06
K843911 ACCESS C Advanced Technology Laboratories, Inc. JOP Class II 1985-03-05
K850454 CARDIO-3 CHANNEL ELECTROCARDIOGRAPH Zimmer Elektromedizin GmbH DPS Class II 1985-03-01
K842976 BRENTWOOD EZ SCAN 200 AMBULATORY ECG Brentwood Instruments, Inc. DSI Class II 1985-03-01
K841944 DISPOSABLE ECG ELECTRODE Bristol Medical Electronics Corp. DRX Class II 1985-03-01
K850155 ECG PATIENT MONITOR 302 Rigel Medical Electronics, Inc. DRT Class II 1985-03-01
K840169 PHONOANGIOGRAPHIC SPECTRAL ANALYZER Biotronics Instruments DPW Class II 1985-03-01
K842514 ELECTROCARDIOGRAM DISPOS. ELECTRODE PAD Multi Biosensors, Inc. DRX Class II 1985-03-01
K842037 LS 5 Life Science Instrumentation, Inc. DRT Class II 1985-03-01
K842051 EKG TRANSMITTER MODEL 5134 Instromedix, Inc. DXY Class III 1985-03-01
K842538 ACCUTORR CSM SYSTEM Datascope Corp. DXN Class II 1985-03-01
K842944 MONITORING SYSTEM M720 Burdick Corp. DPS Class II 1985-03-01
K842067 CALCULATING CUFF INFLATOR TD312 D. E. Hokanson, Inc. DXN Class II 1985-03-01
K850156 ECG PATIENT MONITOR 301 Rigel Medical Electronics, Inc. DRT Class II 1985-03-01
K850656 COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM Cook Pacemaker Corp. DXY Class III 1985-03-01
K850356 PRUITT-VASCULAR SHUNTS Ideas For Medicine, Inc. DWF Class II 1985-02-27
K850085 DISPOSABLE ECG ELECTRODES EASATRACE Medical Device Marketing DRX Class II 1985-02-27
K850341 CARDIOVASCULAR SET UP Marwood Medical, Inc. DQO Class II 1985-02-25
K850337 CARDIAC CATHETERIZATION PACK Marwood Medical, Inc. DRE Class II 1985-02-25
K850114 C/PES 9201, ECG STRESS TESTING SYS Gould, Inc. DRT Class II 1985-02-22
K844856 ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON Bristol Medical Electronics Corp. DRX Class II 1985-02-20
K844220 ARIES MEDICAL PERFLEX PERCUTANEOUS 40CC D/L BALLOO Aries Medical, Inc. DSP Class II 1985-02-20
K844631 PERIFLUX PF-2 Medex, Inc. DPW Class II 1985-02-20
K844277 OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR Omikron Scientific, Ltd. DXG Class II 1985-02-15
K844857 PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD Pacesetter Systems DTD Class II 1985-02-14
K842318 YKI-770 ELECTRONIC SPHYGMOMAMETER Yukosha Co., Inc. DXN Class II 1985-02-14
K844940 SPACELABS MODEL 90201 HOLTER RECORDER Spacelabs, Inc. DSH Class II 1985-02-14
K850170 HEART AID MODEL 97 Cardiac Resucitator Corp. DRO Class II 1985-02-14
K843595 CARDIOTOMY RESERVOIR W/FILTER Omnis Surgical, Inc. DTN Class II 1985-02-14
K843888 CARDIOTOMY RESERVOIR BRS-XXX SERIES & Gish Biomedical, Inc. DTN Class II 1985-02-14
K843944 PTCA BALLOON CATHETERS & ACCESSORIES Advanced Cardiovascular Systems, Inc. LOX Class II 1985-02-14
K842388 COPAL DIGITAL SPHYGMOMANOMETER UA-510 Takeda Medical, Inc. DXN Class II 1985-02-13
K844804 LIFESOUND - ELECTRONIC STETHOSCOPE Biomedical Concepts, Inc. DQD Class II 1985-02-13
K844665 COMPUTER Burdick Corp. DXG Class II 1985-02-13
K850146 SIREDOC, PAPER CHART RECORDER Siemens Medical Solutions USA, Inc. DSF Class I 1985-02-12
K844740 MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT Hewlett-Packard Co. LDD Class II 1985-02-12
K844957 MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR Medtronic Vascular DXY Class III 1985-02-08
K831235 IABP #90 SYSTEM Datascope Corp. DSP Class II 1985-02-08
K844966 CARDIOBEEPER PROFILE MONITOR Survival Technology, Inc. DXH Class II 1985-02-08
K844958 MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE Medtronic Vascular DXY Class III 1985-02-08
K833828 PERCOR 9.5 FR IAB ON DATASCOPE CO2 Datascope Corp. DSP Class II 1985-02-08
K850113 C/PES 9103, ECG STRESS TESTING SYSTEM Gould, Inc. DRT Class II 1985-02-08
K844284 COPAL DIGITAL SPHYGMOMANOMETER UA-540 Takeda Medical, Inc. DXN Class II 1985-02-08
K844793 SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR Intermedics, Inc. DXY Class III 1985-02-08
K850021 ELECTROCARDIOGRAPH-ECG CALIPER Devcom, Inc. DPS Class II 1985-02-08
K850043 CARDIOGUARD STRESS TEST MONITOR 4002 Del Mar Avionics DRT Class II 1985-02-08
K840756 BIOPATCH BOVINE PERICARDIAL PATCH Meadox Medicals, Div. Boston Scientific Corp. DQX Class II 1985-02-08
K842716 MDE ESCORT 1000 & MDE ESCOR 2000 Medical Data Electronics DXH Class II 1985-02-08
K841451 BIOTRONIK DY-UNIPOLAR Biotronik Sales, Inc. DTD Class II 1985-02-07
K841083 QUIKPAGE ARRHYTHMIA REPORT GENERATOR Agilent Technologies DSI Class II 1985-02-07
K841450 BIOTRONIK DNP UNIPOLAR Biotronik Sales, Inc. DTD Class II 1985-02-07
K840869 SURGICAL MODULE 7000 ECG Marquette Electronics, Inc. DPS Class II 1985-02-06
K850136 CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM Cardio Data DSI Class II 1985-02-01
K840037 MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC Smec, Inc. DSP Class II 1985-02-01
K843777 SEAMED 4000 Seamed Corp. DTE Class II 1985-02-01
K843555 CARDIAC COMPUTER SP1445 Gould, Inc. DXG Class II 1985-02-01
K844888 SPACELABS SERIES 600 PATIENT MONITORS Spacelabs, Inc. DRT Class II 1985-02-01
K842908 VARIABLE PRIME COBE MEMBRANE LUNG Cobe Laboratories, Inc. DTZ Class II 1985-02-01
K843807 SEAMED MODEL 6000 Seamed Corp. DTE Class II 1985-02-01
K841084 ARRHYTHMIA SYSTEM AC-11 Fukuda Denshi USA, Inc. DSI Class II 1985-02-01
K844598 LARIAT CATHETER Mallinckrodt Critical Care DQO Class II 1985-02-01
K844687 MEDTRONIC MODEL 6912 Medtronic Vascular DTD Class II 1985-02-01
K843977 PULSE-AID DEVICE James J. Lally LIX Class II 1985-02-01
K843643 COLOR DOPPLER 880 Irex Corp. DXK Class II 1985-01-31
K841254 CARDIOVIT CV-3 Schiller AG DPS Class II 1985-01-24

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