meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
1984-05-16

Clearances · page 168 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K841073 QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE Intermedics, Inc. DXY Class III 1984-05-16
K840737 IMPLANTABLE PROGRAMMABLE PULSE GENER Telectronics, Inc. DXY Class III 1984-05-16
K841074 CARDIAC PULSE GENERATOR 254-18 Intermedics, Inc. DXY Class III 1984-05-16
K833799 SPHYGOMANO METER Fraser Harlake, Inc. DXN Class II 1984-05-14
K834602 SWITCHING UNIT ELECTRODE CATHETER Webster Laboratories, Inc. DRF Class II 1984-05-09
K833973 MINOLTA SM-32 OXYGEN SATURATION MONIT Marquest Medical Products, Inc. DQA Class II 1984-05-09
K833593 FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN Brentwood Instruments, Inc. DPS Class II 1984-05-09
K833819 M305 Burkick Corp. DXJ Class II 1984-05-09
K833951 E 310 ELECTROCARDIOGRAPH Burdick Corp. DPS Class II 1984-05-09
K832828 CENTURION CARDIAC DETECTOR Clinical Data Instruments, Inc. DRJ Class I 1984-05-09
K840228 HEALTHCHECK AUTO INFLATE DIGITAL BP Timex Medical Products Corp. DXN Class II 1984-05-09
K834034 MODEM ACCESSORY FOR EPI CARDIA SYS Medicomp, Inc. DXH Class II 1984-05-09
K833656 NARCOTRACE 40 - NT40 Narco Bio-Systems DSF Class I 1984-05-09
K832429 CARDIO TRACE ELECTRODE Poly-Med Splint Co. DRX Class II 1984-05-09
K840701 PACEMAKER 147 VVI-THE OPTINIA Telectronics, Inc. DXY Class III 1984-05-02
K834567 Q3000 Quinton, Inc. DQK Class II 1984-04-30
K841175 WILLIAM HARVEY H-4720 NON-FILTERED CAR C.R. Bard, Inc. DTN Class II 1984-04-25
K840797 MALE-MALE LUER LOCK CONNECTOR W/ROTA American Pharmaseal Div. Ahsc DTL Class II 1984-04-24
K834416 LUMELEC ELECTRODE CATHETER Cordis Corp. LDF Class II 1984-04-24
K840610 SCIMED MODEL SC4000 Scimed Life Systems, Inc. DTP Class II 1984-04-24
K834232 VAS-CATH DSA CATHETER/TRAY Vas-Cath of Canada , Ltd. DQY Class II 1984-04-24
K833756 SYSTEM 5000 Medical Graphics Corp. DXG Class II 1984-04-24
K840305 CATEGORY 1 CIRCULATORY SYSTEM DEVICE Imm Enterprises , Ltd. DWS Class I 1984-04-23
K840353 PACEMAKER PULSE GENERATOR W/ELECTRODE Ross Research, Inc. DRO Class II 1984-04-23
K840603 ARTERIAL FILTER PURGE LINE W/CHECK VALV Shiley, Inc. DTL Class II 1984-04-19
K832721 DIGITAL SPHYGMOMANOMETER UA-231 Copal, Inc. DXN Class II 1984-04-19
K841410 BUSH NECK W/TAP Warne Surgical Products, Ltd. DRM Class II 1984-04-18
K840914 ARGYLE TAPERED VASCULAR SHUNT Sherwood Medical Co. DWF Class II 1984-04-17
K841032 HOLDER FOR MODELS AF-10,1025,1040,5 American Bentley KRI Class I 1984-04-17
K840749 GAST STAT MONITORING SYSTEM Cardiovascular Devices, Inc. DTY Class II 1984-04-17
K840612 PEDIATRIC ARTERIAL BLOOD FILTER American Bentley DTM Class II 1984-04-17
K832722 DIGITAL SPHYGMOMANOMETER UA-251 Copal, Inc. DXN Class II 1984-04-17
K834134 SARNS 8.0 SOFT ARC CANNULA 3M Health Care, Sarns DWF Class II 1984-04-17
K840923 ANGIOGRAPHY NEEDLE W/WO CONNECTION Dlp, Inc. DYB Class II 1984-04-17
K840450 SHILEY PREBYPASS FILTER Shiley, Inc. KRJ Class II 1984-04-17
K833645 CONTRAST MEDIA INJECT. SET CMS Gish Biomedical, Inc. DXT Class II 1984-04-17
K834397 HOLTER CARDIOGRAPHY SYS 6201 Instruments For Cardiac Research DSI Class II 1984-04-17
K833349 EVENT TAPE RECORDER 8293 Aequitron Medical, Inc. DSH Class II 1984-04-17
K840281 ANGIOGRAPHIC DRAPE PACKS Medrad, Inc. DXT Class II 1984-04-17
K833348 RESPIRATION/8100-HEART RATE RECORDER Aequitron Medical, Inc. DSH Class II 1984-04-17
K841071 PRESSURE MANOMETER Interventional Medical, Inc. DQX Class II 1984-04-17
K840560 NEONATAL PHYSIOLOGICAL MONITOR 903 Novametrix Medical Systems, Inc. DRT Class II 1984-04-17
K841079 WILLIAM HARVEY H-4700 FILTER/CARDIO C.R. Bard, Inc. DTN Class II 1984-04-17
K841148 MINI PECG-MODIFICATION Intersect Systems, Inc. DPS Class II 1984-04-17
K840240 MICROFUSE INTRAVENOUS CATHETER SET Norton Performance Plastics Corp. DQY Class II 1984-04-17
K832723 DIGITAL SPHGMOMANOMETER UA-271 Copal, Inc. DXN Class II 1984-04-17
K834597 ALPHA MASS STORAGE CARDULE 1895 Spacelabs, Inc. DSI Class II 1984-04-17
K840274 CARDIOFAX ECG 6543 Nihon Kohden America, Inc. DRS Class II 1984-04-17
K840246 MINI-DEFIBRILLATOR 280/4 Life Science Instrumentation, Inc. LDD Class II 1984-04-17
K833830 3-DAY BIOINDICATOR RELEASE PROCESS FOR Shiley, Inc. DWF Class II 1984-04-12
K834445 MEDI-TRACE QUIKSET DX DIAG. ELECT- Graphic Controls Corp. DRX Class II 1984-04-01
K833914 CARDIAC OUTPUT SIGNAL ACQUISTION Hewlett-Packard Co. DXG Class II 1984-03-22
K832897 MODEL TTPM TIME TEMP. PRESSURE MONITOR Electromedics, Inc. DRS Class II 1984-03-22
K833913 HEMODYNAMIC PLUG-IN MODULE 78551A Hewlett-Packard Co. DXG Class II 1984-03-22
K832025 SERVOMED COMPACT MONITOR SMK 155-7/101 Litton Medical Electronics DRT Class II 1984-03-22
K832095 SEVOMED COMPACT MONITOR SMK 154- Litton Medical Electronics DRT Class II 1984-03-22
K833676 SURGICAL VESSEL DILATORS-CATHERIZA- Cimed Intl., Inc. DWP Class II 1984-03-19
K834074 PERCUTANEOUS SHEATH INTRODUCER TRAY Packaging Technologies, Inc. DYB Class II 1984-03-19
K840529 STEIGER TUNNELING INSTRUMENT 285 Evermed, Inc. DRC Class II 1984-03-12
K832369 VASCULAR RECORDER #301 Imex Medical Systems, Inc. JOP Class II 1984-03-12
K833554 MATERIAL ADDITION LEXAN & K-RESIN Procedure Products, Inc. DQO Class II 1984-03-12
K840671 CARDIAC CATHETERIZATION PACK Professional Medical Services DRE Class II 1984-03-12
K831926 IMPLANTABLE ENDOCARDIAL PACING LEADS Oscor, Inc. DTG Class I 1984-03-12
K834431 PACING ELECTRODE Pacesetter Systems DTB Class III 1984-03-12
K833801 RIGHT CORONARY GUIDING CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1984-03-12
K833978 OMEGA 5000 Invivo Research Labs, Inc. DXN Class II 1984-03-09
K840251 PATIENT MONITOR 78534B Hewlett-Packard Co. DRT Class II 1984-02-27
K840256 CARDIOPLEGIA HEAT EXCHANGER HOLDER American Bentley DTR Class II 1984-02-17
K832951 MEMORY LOOP TRANSMITTER #121 Biometric Products, Inc. DXH Class II 1984-02-17
K840336 RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI Arrow Intl., Inc. DQY Class II 1984-02-17
K840002 ARTERIAL CANNULA CURVED BEVELED TIP Dlp, Inc. DWF Class II 1984-02-13
K840001 ARTERIAL CANNULA STRAIGHT BEVELED TIP Dlp, Inc. DWF Class II 1984-02-13
K840045 CARDIOPLEGIA HEAT EXCHANGER HE-100 American Bentley DTR Class II 1984-02-13
K834223 CARDIOVASCULAR SPRING GUIDE WIRE Mallinckrodt Critical Care DQX Class II 1984-02-13
K833427 IMPLANTABLE BIPOLAR CARDIAC PULSE GEN Telectronics, Inc. DXY Class III 1984-02-10
K833899 TDK ECG ELECTRODE MEL-08 Tdk Corp. DRX Class II 1984-02-10
K840175 DOUBLE LUMEN INFUSION CATHETERS Medical Components, Inc. DQY Class II 1984-02-10
K833428 IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN Telectronics, Inc. DXY Class III 1984-02-10
K833728 CARDIAC WALL MOTION DEVICE Intl. Medical, Inc. DSB Class II 1984-02-10
K833792 TRANTECSILICONE QUARTZ DISP. TRANSD American Bentley DRS Class II 1984-02-10
K834040 MINATURE PRESSURE TRANSDUCER Carbomedics, Inc. DXO Class II 1984-02-10
K834373 CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 American Bentley DTN Class II 1984-02-04
K840022 HEART CATHETERIZATION TRAY SET Medi-Plast Intl., Inc. DRE Class II 1984-02-04
K833555 LAL TEST RELEASE & BONCHEK CAR/JACKET Shiley, Inc. DTR Class II 1984-02-04
K834459 DIAGNOSTIC RADIOLOGY CATHETERS American Edwards Laboratories DQO Class II 1984-02-04
K840109 ELECATH HEPARIN COATED TEMP. PACING Electro-Catheter Corp. LDF Class II 1984-02-04
K834262 TRANS-PACE Micromedical Devices, Inc. DRO Class II 1984-02-04
K840167 PORTABLE DEFIBRILLATOR Honeywell, Inc. LDD Class II 1984-02-04
K834237 GRADUATED GUIDE WIRE BOWL 8 Sterile Design, Inc. DQX Class II 1984-02-04
K840047 LIFEPAK 7D Physio-Control Corp. DRO Class II 1984-02-04
K834109 MAHURKAR DUAL LIMEN FEMORAL CATHETER Quinton, Inc. DQY Class II 1984-02-04
K834342 CCS MODEL AV-102 IMPLANTABLE A-V DATA Cardiac Control Systems, Inc. DTB Class III 1984-02-04
K840017 VERTEX PERCUTANEOUS CATHETER INTRODUC Professional Medical Services DRE Class II 1984-02-04
K834275 SOFTIP CATHETER Angiomedics, Inc. DQO Class II 1984-02-04
K833836 IL HEPARINIZED FLOW DIRECTED THERMAL Instrumentation Laboratory CO DYG Class II 1984-02-04
K834257 CARDIODATA PACE RECORDER Cardio Data DSH Class II 1984-01-30
K833519 PULSE GENERATOR MODEL 688 Burditt & Calkins-Siemens-Elema DXY Class III 1984-01-30
K833918 INFUSION PORT BALLOON THERMODILUTION Critikon Company, LLC DYG Class II 1984-01-30
K834533 ELECTRODE LEAD CONSTRUCTION Telectronics, Inc. DTB Class III 1984-01-30
K833572 HEPARIN-COATED BALLOON THERMODILUT Critikon Company, LLC DYG Class II 1984-01-30

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