meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
36
Latest Decision
1983-05-18

Clearances · page 172 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K830684 NORELCO ELECTRONIC DIGITAL BLOOD PRESS North American Philips Corp. DXN Class II 1983-05-18
K830795 CABINET FOR MULTIPLE FUNCTION BLOCKS Electronics For Medicine, Inc. DRT Class II 1983-05-18
K830686 ANEROID BLOOD PRESSURE CUFF #HC1400 North American Philips Corp. DXN Class II 1983-05-18
K830687 NORELCO ELECTRONIC ANALOG BLOOD PRESS North American Philips Corp. DXN Class II 1983-05-18
K830876 PREP-CHECK General Devices KRC Class II 1983-05-18
K830823 Z VIEW METER MODEL 300 Lintronics Industries, Inc. KRC Class II 1983-05-18
K831190 VESSEL DILATOR Medrad, Inc. DRE Class II 1983-05-09
K831157 BLOOD CARDIOPLEGIA STAINLESS STEEL COOL American Bentley DTR Class II 1983-05-09
K831184 CARDIO DATA PACEMAKER RECORDER Cardio Data DSH Class II 1983-05-09
K830477 CARDIOMEMO III Instromedix, Inc. DXH Class II 1983-05-09
K831189 ANGIOGRAPHIC NEEDLE Medrad, Inc. DQO Class II 1983-05-09
K830779 PRESSURE FUNCTION BLOCK FOR BLOOD PRESS Honeywell, Inc. DRT Class II 1983-05-09
K831160 LEAD ADAPTERS #'S 6016,6022,6017 ETC Cardiac Pacemakers, Inc. DTD Class II 1983-05-09
K830743 POROUS TIP ENDOCARDIAL LEAD Daig Corp. DTB Class III 1983-05-09
K823893 MODEL MZ PACEMAKER LEAD-VARIOUS Oscor, Inc. DTB Class III 1983-04-30
K823897 MODEL SF. D&SX.D PACEMAKER LEADS Oscor, Inc. DTB Class III 1983-04-30
K830788 CENTRAL VEIN CATHERIZATION KIT-14-690- Norton Performance Plastics Corp. DQO Class II 1983-04-30
K823895 MODEL RF. D&RX..D PACEMAKER LEADS Oscor, Inc. DTB Class III 1983-04-30
K823894 MODEL RZ PACEMAKER LEAD VARIOUS Dr. Ing. P. Osypka, GmbH DTB Class III 1983-04-30
K823896 MODEL FF..D & FX..D PACEMAKER LEADS Dr. Ing. P. Osypka, GmbH DTB Class III 1983-04-30
K823898 MODEL MF..D & MX..D PACEMAKER LEADS Oscor, Inc. DTB Class III 1983-04-30
K823892 MODEL SZ PACEMAKER LEAD-VARIOUS Dr. Ing. P. Osypka, GmbH DTB Class III 1983-04-30
K823889 MODEL JY PACEMAKER LEAD - VARIOUS Oscor, Inc. DTB Class III 1983-04-30
K822617 VPD540 DEFIBRILLATOR Life Science Instrumentation, Inc. LDD Class II 1983-04-28
K830663 PENCIL SKIN ABRADER Ndm Corp. DRX Class II 1983-04-28
K830828 IMPLANTABLE PACING LEAD CCS MODEL SV-101 Cardiac Control Systems, Inc. DTB Class III 1983-04-28
K830415 DIAGNOSTIC INTRAVASCULAR CATHETER Mallinckrodt Critical Care DQO Class II 1983-04-28
K830829 CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DYB Class II 1983-04-28
K830813 FRENCH PERCUTANEOUS SHEATH INTRODUCER Norton Performance Plastics Corp. DYB Class II 1983-04-28
K830728 CARDIOVASCULAR DISPOSABLE PRODUCTS Electromics, Inc. DWF Class II 1983-04-28
K831056 DEFIBRILLATOR VPD 545 Life Science Instrumentation, Inc. LDD Class II 1983-04-28
K830410 EK COMBI MSG-1 Jedmed Instrument Co. DSP Class II 1983-04-27
K830411 MINISCOPE MS-2 Jedmed Instrument Co. DSP Class II 1983-04-27
K830782 LIFELINE ENDOCARDIAL PACING LEAD #479-05 Intermedics, Inc. DTB Class III 1983-04-18
K830638 PHYSIOLOGICAL PRESSURE MEASUREMENT SYS Camino Laboratories, Inc. DXO Class II 1983-04-18
K830772 TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 Oscor, Inc. LDF Class II 1983-04-18
K830950 VASCULAR PRODUCTS IMPLANTABLE PACING Oscor, Inc. DTB Class III 1983-04-18
K830733 FORGARTY CHIN PERIPHERAL INTRAOPERATIVE American Edwards Laboratories LIT Class II 1983-04-18
K830210 DISPOSABLE PRESSURE TRANSDUCER American Pharmaseal Div. Ahsc DRS Class II 1983-04-18
K830909 MIKRO-TIP CATH. PRESSURE TRANSDUCER Millar Instruments, Inc. KRB Class II 1983-04-18
K830282 ELECTRONIC EXERCISE #313-PULSE RATE Walton Manufacturer Co. DRT Class II 1983-04-14
K830184 SPHYGMOLOG II MODEL D Cardiodyne General, Inc. DXN Class II 1983-04-12
K830899 THREE CHANNEL MONITOR SERIES 6700 Marquette Electronics, Inc. DXJ Class II 1983-04-12
K830519 CHALLENGER #450 Transmed, Inc. DSH Class II 1983-04-12
K823931 DEFIGARD M(OR DEFISCOPE M Odam LDD Class II 1983-04-12
K823933 MINIDEF (OR DEFIPORT Odam LDD Class II 1983-04-12
K830734 FORGARTY BALLOON CALIBRATOR American Edwards Laboratories DQO Class II 1983-04-12
K823586 COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200 Brentwood Instruments, Inc. DSI Class II 1983-04-06
K823585 COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13 Brentwood Instruments, Inc. DSI Class II 1983-04-06
K830727 CARDIOTOMY RESERVOIR-FILTERED & NON Electromics, Inc. DTP Class II 1983-04-05
K830910 MANOMETER SET C.V.P. #S 298/299 Exco, Inc. KRK Class II 1983-04-05
K823890 MODEL ZY PACEMAKER LEAD-VARIOUS Oscor, Inc. DTB Class III 1983-03-31
K830029 SIRECUST 400 Analogic Corp. DSI Class II 1983-03-31
K823891 MODEL KY PACEMAKER LEAD - VARIOUS Oscor, Inc. DTB Class III 1983-03-31
K830315 DUAL CHANNEL RECORDER #78574A Hewlett-Packard Co. DSF Class I 1983-03-31
K830025 DIGITAL SUBTRACTION ANGIOGRAPHY CONVEN- Medrad/Technology For People DQO Class II 1983-03-31
K830368 AMBULATORY BLOOD PRESSURE MONITOR Vita-Stat Medical Services, Inc. DXN Class II 1983-03-31
K823843 FREEMAN ACETABULAR CUP Depuy, Inc. DXQ Class II 1983-03-29
K830327 DOSIMETRIC RELEASE OF RADIATION DEV American Bentley DTZ Class II 1983-03-24
K830390 IMPLANTABLE BIPOLAR CARDIAC PULSE GEN Telectronics, Inc. DXY Class III 1983-03-24
K823878 IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 Pacesetter Systems DXY Class III 1983-03-24
K823334 PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630 Psitron DRS Class II 1983-03-24
K830407 ECLIPSE Diagnostic Medical Instruments DSI Class II 1983-03-24
K822873 DEVETHERM Eko Scann AB DQB Class II 1983-03-24
K830637 VERTEX DIGITAL SUBSTRATION KIT Professional Medical Services DQO Class II 1983-03-24
K823764 SCANLAN SINGLE-USE AORTA PUNCH Scanlan Intl., Inc. DWS Class I 1983-03-24
K830471 KELLY-WICK TANNELER Intl. Medical Prosthetics Research DWS Class I 1983-03-24
K823754 SAHOTA-KAPLAN HEMOSTAT Erickson Industries, Inc. DQO Class II 1983-03-24
K830608 USCI GRUNTZIG DILACA BALLOON DILATION C.R. Bard, Inc. LIT Class II 1983-03-24
K830432 CENTRAL STATION 590 Kone Instruments, Inc. DRT Class II 1983-03-24
K830609 INFLATION DEVICE Interventional Medical, Inc. DXT Class II 1983-03-24
K830433 PATIENT MONITOR 575 Kone Instruments, Inc. DRT Class II 1983-03-24
K823828 THERACARD 400 Siemens Medical Solutions USA, Inc. LDD Class II 1983-03-17
K830306 HEARTRATE PLUS ECG CARDULE #1918 Spacelabs, Inc. DSI Class II 1983-03-17
K830457 PACING LEAD #PMA F 860 Ela Medical, Inc. DTB Class III 1983-03-17
K830576 LYMPHANGIOGRAPHY SET Vertex Medical Corp. DQO Class II 1983-03-17
K830382 COMMAND ULTRA II Cardiac Pacemakers, Inc. DXY Class III 1983-03-17
K830401 UNILITH PULSE GENERATOR VVI #7542 Ela Medical, Inc. DXY Class III 1983-03-17
K823831 MEDTRONIC MODELS 59401 5941 Medtronic Vascular DXY Class III 1983-03-16
K830464 PACEMAKER ELECTRODE PERM. & TEMP Daig Corp. DTB Class III 1983-03-16
K830523 CATHETER CONNECTION W/INTEGRAL INJECTATE Gould, Inc. DQO Class II 1983-03-16
K823357 VARIOUS CARDIOVASCULAR PRODUCTS C.R. Bard, Inc. DQO Class II 1983-03-11
K830167 HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA- American Bentley KRI Class I 1983-03-11
K830003 MICRO FITNESS COMPUTER Microfit, Inc. DXG Class II 1983-03-10
K823345 PATCH Shiley, Inc. DXZ Class II 1983-03-10
K823863 CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC Intermedics, Inc. DXY Class III 1983-03-10
K823906 TELEMETRY SYSTEM Transkinetic Systems, Inc. DRG Class II 1983-03-09
K830150 VEINPREP VEIN GRAFT PREP. KIT A277723 Atrium Medical Corp. DWD Class II 1983-02-28
K830463 LIFELINE UNIPOLAR J-LEAD #483-05 Intermedics, Inc. DTB Class III 1983-02-28
K830149 IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- Instrumentation Laboratory CO DWD Class II 1983-02-28
K830013 EPI CARDIA SYS. - AMBULATORY MONITOR Medicomp, Inc. DSI Class II 1983-02-28
K830420 POLYETHYLENE MONITORING CONNECTORS Vertex Medical Corp. DQO Class II 1983-02-28
K823758 CENTRAL VEIN CATHERIZATION KIT Access Devices, Inc. DQO Class II 1983-02-23
K830237 TRANSLUCENT POLY. CATH. CONNECTOR AND Vertex Medical Corp. DQO Class II 1983-02-18
K830094 USCI TEMP. ATRIO-VENTRICULAR ELECTRODE C.R. Bard, Inc. LDF Class II 1983-02-18
K823920 COEURLOCK STERILE DISPOS. ANGIOGRAPHIC Coeur Laboratories, Inc. DXT Class II 1983-02-18
K830163 IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS Intl. Business Machines DSI Class II 1983-02-18
K823739 INTRA-AORTIC BALLOON SYSTEM Smec, Inc. DSP Class II 1983-02-18
K822639 AFP SYSTEM PULSE GENERATOR MODEL 261/262 Pacesetter Systems DXY Class III 1983-02-18
K823559 AFP PULSE GENERATOR Pacesetter Systems DXY Class III 1983-02-18

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