meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
1980-10-10

Clearances · page 182 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K802328 DISP. TOUGY-BORST TYPE ADAPTOR W/PORT Stanco Medical, Inc. DTZ Class II 1980-10-10
K802260 VASCULAR CATHETER WIREGUIDES Stanco Medical, Inc. DQX Class II 1980-10-10
K802095 GORE-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1980-10-10
K802327 SHEATH DILATOR SET Stanco Medical, Inc. DRE Class II 1980-10-10
K802261 PRESSURE GAUGE ACCESSORY KIT/DILATATION Stanco Medical, Inc. DWF Class II 1980-10-03
K802204 CT-1600 DIGITAL PULSE RATE MONITOR Industrial & Biomedical Sensors Corp. DRT Class II 1980-10-03
K802273 TELEMETRY TRANSMITTER, #TLT-3 Bd Becton Dickinson Vacutainer Systems Preanalytic DRG Class II 1980-10-03
K802244 VESSEL RETRACTOR, #600732 Bentley Laboratories, Inc. DXC Class II 1980-10-03
K802203 CM-700A AUTO-INFLATE CONTROL MODULE Industrial & Biomedical Sensors Corp. DXN Class II 1980-10-03
K801640 SORIN PULSE GENERATOR, MODEL #LIT-214 Bentley Laboratories, Inc. DXY Class III 1980-10-03
K802030 U.I. OCTOSON Ausonics Pty , Ltd. DXK Class II 1980-10-03
K802236 CORROSION PROOF SNAP ECG CONNECT WIRES Custom Cardio Components DSA Class II 1980-10-03
K802237 CORROSION PROOF DUAL PURPOSE ECG WIRES Custom Cardio Components DSA Class II 1980-10-03
K801978 PROGRAMALITH #'S 221, 222, 221A & 222A Pacesetter Systems DXY Class III 1980-09-26
K800944 MEDTRONIC MODEL 69575 Medtronic Vascular DTB Class III 1980-09-26
K802198 BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM Biometric Analysis Group, Inc. DXG Class II 1980-09-26
K802103 ECG RECALL & EDIT PRODUCT VERSION-A3601 General Electric Co. DSI Class II 1980-09-26
K800519 HEARTWATCH D. Jenkins DRT Class II 1980-09-26
K801063 HALL ARTERIAL OSCILLATOR American Sterilizer Co. DWX Class II 1980-09-26
K802184 HS10 PORTABLE OPERATING ROOM MONITOR Medtel Pty. , Ltd. DRT Class II 1980-09-26
K802076 STIFF STYLETS Cardiac Pacemakers, Inc. DRB Class II 1980-09-26
K802133 BENTLEY THEROMODILUTION CATHETER #BTD-7F Bentley Laboratories, Inc. KRB Class II 1980-09-26
K802033 OXFORD INTENSIVE CARE PATIENT MON. SYS Oxford Medilog, Inc. DSI Class II 1980-09-26
K802089 CARDIOTRAK Cardiac Pacemakers, Inc. DXH Class II 1980-09-26
K802028 IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN Telectronics, Inc. DXY Class III 1980-09-26
K800379 BIFOCAL 2 8200 SERIES (A,B C,D) American Pacemaker Corp. DXY Class III 1980-09-26
K802272 COMPUTER ECG TERMINAL Compumed, Inc. DSI Class II 1980-09-26
K800793 IMPLANTABLE PROGRAM. CARDIAC PACEMAKER Telectronics, Inc. DXY Class III 1980-09-18
K802119 SHILEY UTILITY RESERVOIR Shiley, Inc. DTN Class II 1980-09-16
K801508 SIEMENS-ELEMA PULSE GENERATOR 625 Siemens Elema AB DXY Class III 1980-09-16
K801596 CYNERGY MODEL 184 Cynergy DTE Class II 1980-09-16
K802079 DEKNATEL GOOSEN VASCULAR PUNCH BLADES Howmedica Corp. DWS Class I 1980-09-16
K802069 DISP. TRANSDUCER DOMES TD200 & TD300 Bio-Med Corp. DRS Class II 1980-09-09
K801831 EVALUATOR #9500 DYNAMIC ELEC/SCANNER Del Mar Avionics DSI Class II 1980-09-09
K801910 INSULATING SHEATH Cordis Corp. DXY Class III 1980-09-09
K800226 MEDTRONIC MODEL 2409 Medtronic Vascular DXY Class III 1980-09-09
K801885 HANCOCK * OBTURATORS Hancock Laboratories, Inc. DTI Class I 1980-09-09
K802040 BATTERY FOR #229-01 PULSE GENERATOR Intermedics, Inc. DXY Class III 1980-09-09
K801811 PALPATION ENHANCER Medical Horizons Co. LDE Class I 1980-09-09
K801846 ELECTROCARDIOGRAPH ELECTRODE Phoenix Glove Co. DRX Class II 1980-09-09
K801806 EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE Arco Medical Products Co. DXY Class III 1980-09-09
K801621 VASCULAR GRAFT PROSTH. OF EXP. MICRO. Impra, Inc. DSY Class II 1980-09-09
K801985 BIO-MED CORP. DISP. NON-STERILE TRANSDU Bio-Med Corp. DRS Class II 1980-09-09
K801923 BIOMEGA #423-B BLOOD PRESSURE & PULSE CK Bio Mega Diagnostic, Inc. DXN Class II 1980-08-27
K801763 VIVALITH 5, - MDL-201A & TDL-201A Pacesetter Systems DXY Class III 1980-08-27
K801830 MODEL 9300 ELECTROCARDIOVALIDATOR Del Mar Avionics DSF Class I 1980-08-27
K801828 MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS Graphic Controls Corp. DTL Class II 1980-08-27
K801829 MEDI-TRACE DISP. FLUSHING DEV./MONITOR Graphic Controls Corp. KRA Class II 1980-08-27
K801832 MODEL 9200 VIS-U-SCAN Del Mar Avionics DSH Class II 1980-08-27
K801762 MICRO-PROCESSOR UNIT #A3600AC General Electric Co. DSI Class II 1980-08-27
K801761 PDS COMPUTER UNIT/VIDEO TERMINAL General Electric Co. DRT Class II 1980-08-20
K801865 CORDIS FLOW DIRECTED BALLOON CATHETER Cordis Corp. DYG Class II 1980-08-20
K801756 MMI/GAELTEC CATHETER TIP TRANSDUC Medical Measurements, Inc. DXO Class II 1980-08-20
K801647 SONACOLOR 6100 Carolina Medical Electronics DXY Class III 1980-08-20
K801657 NON-INVASIVE, BLOOD PRESSURE MONITOR Biochem International, Inc. DXN Class II 1980-08-20
K801450 INTERMEDICS THIN LITH IV SERIES UNIPOLAR Intermedics, Inc. DXY Class III 1980-08-14
K800696 ELECTRONIC PACEMAKER WAVEFORM ANALYZER Instromedix, Inc. KRE Class II 1980-08-14
K801764 IONESCU-SHILEY PERICARDIAL PATCH Shiley, Inc. DXZ Class II 1980-08-13
K801677 ELECTROCARDIOGRAPH, MODEL ECG-5503 Nihon Kohden America, Inc. DPS Class II 1980-08-07
K801700 UNI-RECORD I Bd Becton Dickinson Vacutainer Systems Preanalytic DXH Class II 1980-08-07
K801770 ARTERIAL BUBBLE TRAP Delta Medical Industries DWF Class II 1980-08-07
K801650 DESERET EMBOLECTOMY/THROMBECTOMY CATH. Deseret Medical, Inc. DXE Class II 1980-08-04
K801113 DILATOR, VESSEL, FOR PERC. CATHETER. Alva Medical, Inc. DRE Class II 1980-07-28
K801568 SHIELD DISPOSABLE BLOOD PRESSURE CUFF American Convertors Div., American Pharmaseal DXQ Class II 1980-07-28
K801389 BARO/TRAC II & VITA/TRAC, VITAL SIGN MON Bib, Inc. DXN Class II 1980-07-28
K801031 BLADE SEPTOSTOMY CATHETER Cook, Inc. DXF Class II 1980-07-28
K801641 OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT Ohio Medical Products DTS Class II 1980-07-28
K801359 PRUITT VASCULAR SHUNT Ideas For Medicine, Inc. DWF Class II 1980-07-28
K801552 MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR Edwards Laboratories KRB Class II 1980-07-28
K800805 LINEAR ARRAY SCANNER Philips Medical Systems (Cleveland), Inc. DXK Class II 1980-07-21
K800553 ULTRA IMAGER Honeywell, Inc. DXK Class II 1980-07-21
K800653 SINVISION LINEAR ARRAY REAL TIME Kt Medical, Inc. DXK Class II 1980-07-21
K801039 ADAPTAID HELICAL COIL ADAPTER 365-14 Intermedics, Inc. DTD Class II 1980-07-21
K800850 HIGH STOY SMALL PARTS SCANNER #SP-100B Highstoy DXK Class II 1980-07-21
K800596 VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR Bib, Inc. DXN Class II 1980-07-21
K800405 A-V MINI CLINIC Instromedix, Inc. DRT Class II 1980-07-21
K801239 STERILE, DISP DOME, INDIVID. PKG. Pacific Domes, Inc. DRS Class II 1980-07-14
K801549 MODEL R11 SINGLE CHANNEL CHART RECORDER Medasonics, Inc. DSF Class I 1980-07-14
K801544 PORTA-FIB LPD Narco Bio-Systems LDD Class II 1980-07-14
K801360 CARDIOTOMY RESERVOIR WITH FILTER Travenol Laboratories, S.A. DTP Class II 1980-07-14
K801375 SHILEY CARDIOTOMY RESERVOIR W/FILTER Shiley, Inc. DTP Class II 1980-07-14
K801138 MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. Gics Pharmaceuticals DRS Class II 1980-07-14
K801291 EC-4 PLETHYSMOGRAPH D. E. Hokanson, Inc. JOM Class II 1980-07-08
K801485 SERIES 602 CKG RECORDER (MODIFIED) Cardio Kinetics, Inc. DSF Class I 1980-07-08
K801515 ABBY II PATIENT MONITOR OR VITAL SIGNS M Abbott Medical Electronics Co. DRT Class II 1980-07-08
K801038 ADAPTAID ELEMA LEAD ADAPTER KIT 365-17 Intermedics, Inc. DTD Class II 1980-07-08
K801106 MULTICOR (GAMMA) MODEL 336 & MODEL 337 Cordis Corp. DXY Class III 1980-07-08
K801241 UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. Arco Medical Products Co. DXY Class III 1980-06-30
K801399 CORONARY PERFUSION CONNECTOR PLUG Texas Medical Products, Inc. DTL Class II 1980-06-30
K801396 SAPHENOUS VEIN CANNULAE Texas Medical Products, Inc. DWF Class II 1980-06-30
K801122 MICROTHIN-D1 (MOD. 0620) Cardiac Pacemakers, Inc. DXY Class III 1980-06-30
K801405 DISPOSABLE PERFUSION CONNECTORS Texas Medical Products, Inc. DTL Class II 1980-06-30
K801392 DISPOSABLE SUMP SETS Texas Medical Products, Inc. DWF Class II 1980-06-30
K801322 MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS Graphic Controls Corp. DQO Class II 1980-06-30
K801040 GE LEAD ADAPTER, MODEL 345-01 Intermedics, Inc. DTD Class II 1980-06-30
K801321 PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE Graphic Controls Corp. DQO Class II 1980-06-30
K801398 AORTIC AND FEMORAL PERFUSION CANNULAE Texas Medical Products, Inc. DWF Class II 1980-06-30
K801121 MICROTHIN-P1 (MOD. 0622) Cardiac Pacemakers, Inc. DXY Class III 1980-06-30
K801395 VASCULAR CLAMP Texas Medical Products, Inc. DXC Class II 1980-06-30
K801403 DISPOSABLE PERFUSION SET Texas Medical Products, Inc. DWF Class II 1980-06-30

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