meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1982-07-14

Clearances · page 175 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K821324 ARGYLE INTRAMEDICUT CATHETER KIT Sherwood Medical Co. DYB Class II 1982-07-14
K821909 LITTMAN TUNABLE STETHOSCOPE 2136 3M Company LDE Class I 1982-07-14
K820696 MEADOX WOVEN DOUBLE VELOUR Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1982-07-09
K821518 MYO/CLIP Alto Development Corp. LDF Class II 1982-07-08
K820727 CARDIOTOMY RESERVOIRS Erik Perfusion Services DTN Class II 1982-07-08
K821090 CARDI-O-LIFE MODEL 8823 Amertek DPS Class II 1982-07-08
K821189 MULTIPURPOSE CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1982-07-08
K821491 35MM ANGIOGRAM VIEWER ANALYZER Birtcher Corp. DXJ Class II 1982-07-08
K821188 INTRODUCER SET Advanced Cardiovascular Systems, Inc. DYB Class II 1982-07-08
K821535 VITALINE DISPOSABLE EKG ELECTRODE-LEAD The Halverstadt Co. DRX Class II 1982-07-08
K821373 XOMED PATENCY MONITOR Xomed, Inc. DPW Class II 1982-07-08
K820887 MITRAL VALVE ORIFICE SIZER Celtech DTI Class I 1982-07-08
K821726 MODEL 535-02 TRACE-A-PACE TRANSMITTER Intermedics, Inc. DXH Class II 1982-07-08
K821378 NON-INVASIVE AUTOMATIC BLOOD PRESSURE Narco Scientific DXN Class II 1982-07-08
K820600 HANCOCK VASCULAR GRAFT Extracorporeal Medical Specialities, Inc. DSY Class II 1982-07-08
K813264 D6ZO DISPOSABLE HEAT EXCHANGER Electromedics, Inc. DTR Class II 1982-07-06
K821791 EXTERNAL PULSE GENERATOR - EV4542 American Pacemaker Corp. DTE Class II 1982-07-06
K821755 TELCOR 2 Burdick Corp. DRT Class II 1982-07-02
K813355 MODIFICATION OF THE PERCUTAN-BALLOON Smec, Inc. DSP Class II 1982-07-02
K821757 QUIK - PREP2 ELECTRODE Quinton, Inc. DRX Class II 1982-07-02
K821416 DISPOSABLE BLOOD PRESSURE TRANSDUCER Bentley Laboratories, Inc. DRS Class II 1982-07-02
K820044 ARTERIAL BLOOD FILTER, #AF-1025 Bentley Laboratories, Inc. DTM Class II 1982-06-29
K820256 MEDILAC #SR4 & SR 40 Spelna, Inc. DSH Class II 1982-06-25
K821720 PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000 Novametrix Medical Systems, Inc. DRT Class II 1982-06-25
K820939 C-101-P Coratomic, Inc. DXY Class III 1982-06-22
K821442 WILLIAM HARVEY FLEX. VENOUS RESERVOIR C.R. Bard, Inc. DTN Class II 1982-06-17
K821480 RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT The Healthcare Group Laboratories, Inc. DQY Class II 1982-06-17
K821401 MALLINCKRODT DIAG. MEDIA WARMER Forma Scientific, Inc. DXT Class II 1982-06-17
K812262 MEDTRONIC A-V PACING SYSTEM ANALYZER Medtronic Vascular DTC Class II 1982-06-17
K820679 PEDIATRIC ARTERIAL BLOOD FILTER #AF-540 Bentley Laboratories, Inc. DTM Class II 1982-06-17
K820343 ARTERIAL BLOOD FILTER MODEL #AF-1040 Bentley Laboratories, Inc. DTM Class II 1982-06-17
K821223 CR-9 Life Science Instrumentation, Inc. DRT Class II 1982-06-17
K821384 EXERCISE ECG ELECTRODES, REUSABLE Respironics, Inc. DRG Class II 1982-06-17
K821506 MEDICOTEST ECG ELECTRODES Medicotest, Inc. DRX Class II 1982-06-17
K820459 VIRAGARD/VIRASHIELD Tri-Med, Inc. DRS Class II 1982-06-16
K821261 PUIG MASSANA-SHILEY ANNULOPLASTY RING Shiley, Inc. KRH Class II 1982-06-16
K821095 SPHYGURITE Associated Medical Devices, Inc. DXQ Class II 1982-06-10
K820570 SEAMED, #540 - SIEMENS, #146F TELECTRO Seamed Corp. DTE Class II 1982-06-03
K821548 PACEMAKER CONNECTOR PLUG Pacesetter Systems DTD Class II 1982-06-02
K821333 ATRIAL J TEMPORARY PACING ELECTRODESS Medics Instrument Corp. LDF Class II 1982-06-02
K821547 PACEMAKER UNIPOLAR ADAPTER Pacesetter Systems DTD Class II 1982-06-02
K821549 PACEMAKER 445 ADAPTER Pacesetter Systems DTD Class II 1982-06-02
K821216 INTERPULSE MEMBRANE OXYGENATOR Extracorporeal Medical Specialities, Inc. DTZ Class II 1982-06-02
K820854 KENZ-45M Suzuken Co., Ltd. DXN Class II 1982-06-01
K821014 CORATOMIC MODEL OVALITH 920BP Coratomic, Inc. DXY Class III 1982-05-28
K821437 DIGITAL BLOOD PRESSURE METER Timex Medical Products Corp. DXN Class II 1982-05-28
K821033 CORATOMIC MODEL OVALITH-920 Coratomic, Inc. DXY Class III 1982-05-28
K821516 TRACKER-2 CHANNEL ECG TAPE RECORDER Reynolds Medical , Ltd. DSH Class II 1982-05-28
K821569 LEATHER VALVULOTOME American V. Mueller DWS Class I 1982-05-27
K821159 IN-LINE OXYGEN MONITORING SYSTEM G.D. Searle and Co. DRY Class II 1982-05-25
K821450 PRESSURE TUBING-ADULT & PEDIATRIC Gould, Inc. DRS Class II 1982-05-25
K821004 MEDTRONIC S3 TM SYSTEM Medtronic Vascular DYG Class II 1982-05-25
K821368 MODELS 78504A & 78508A PATIENT MON. SYS Hewlett-Packard Co. DRT Class II 1982-05-25
K821232 ONE HAND ANEROID SPHYGMOMANOMETER Abco Dealers, Inc. DXQ Class II 1982-05-25
K821438 RED DOT MONITORING ELECTRODES #2260/65 3M Company DRX Class II 1982-05-25
K820194 CARDIAC CATHERIZATION LAB MICROPROCESS Compu-Cath Corp. DXG Class II 1982-05-25
K820959 BLOOD FLOW ANALYZER Biofax Medical Instrumentation Co. DSB Class II 1982-05-25
K821453 CARDIOCASSETTE II #363 Birtcher Corp. DSH Class II 1982-05-25
K821015 CARE MODEL IP 4500 AUTO SCANNERR Care Monitoring Systems DRT Class II 1982-05-24
K820954 SCIMED MODEL SC 3000 Scimed Life Systems, Inc. DTP Class II 1982-05-24
K813268 SC-2500F CARDIOTOMY RESERVIOR Scimed Life Systems, Inc. DTN Class II 1982-05-18
K821158 FED RINGED-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 1982-05-18
K821137 MEDITRACE PELLET ELECTRODE Graphic Controls Corp. DRX Class II 1982-05-18
K820881 MEMOPORT C Litton Medical Electronics DSI Class II 1982-05-18
K821149 SUBMISSION CORONARY CANNULA Dlp, Inc. DWF Class II 1982-05-18
K820912 PMS-2 PRESSURE MONITOR SEPARATOR Delta Medical Industries DXS Class II 1982-05-18
K821173 EVENTMASTER 3 HOLTER EVENT SCANNER Instruments For Cardiac Research DSF Class I 1982-05-18
K821057 FLOW DIRECTED THERMAL-DILUTION INFUSION Oximetrix, Inc. DYG Class II 1982-05-18
K821235 HEPARIN COATED THERMODILUTION CATHETER Gould, Inc. DYG Class II 1982-05-18
K820667 PRESSURE-STAT Alvin H. Sacks, Ph.D. DXN Class II 1982-05-18
K821099 HEPARIN COATED THERMODILUTION CATHETER Kma, Inc. DYG Class II 1982-05-18
K821073 PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1982-05-07
K821147 COOK #326T PROGRAM/TELEMETRY BIPOLAR Cook Pacemaker Corp. DXY Class III 1982-05-07
K821003 PROGRAMMALITH II, #225 & 226 Pacesetter Systems DXY Class III 1982-05-07
K820986 EKG MONITORS, VARIOUS MODELS Dart Medical Equipment DXH Class II 1982-04-29
K820949 P-S BERLIN VESSEL CLAMP Pudenz-Schulte Medical Research Corp. DXC Class II 1982-04-29
K820166 ADAPTATION OF KANTRON 40 CC. PDLIAB Kontron Instruments, Inc. DSP Class II 1982-04-29
K820820 CARDIO REVUE CENTER Diasonics, Inc. DXG Class II 1982-04-29
K820438 QUINTON Q2000 ETT MONITORING SYSTEM Quinton, Inc. DSI Class II 1982-04-29
K820883 SEPTISLEEVE Argon Medical Corp. DYG Class II 1982-04-29
K820856 EVENTMASTER 2 Instruments For Cardiac Research DSI Class II 1982-04-29
K820814 THERMO-K American Medical Systems, Inc. DWJ Class II 1982-04-29
K820898 VASCULAB SPECTRUM ANALYZER #SP25 Medasonics, Inc. DXG Class II 1982-04-21
K820702 IL 7F FLOW DIRECTOR THERMAL DILU. CATH Instrumentation Laboratory CO DYG Class II 1982-04-21
K820904 EKG TELEPHONE CONVERTER Dart Medical Equipment DXH Class II 1982-04-21
K820014 HOLTER ECG SCANNER Laser Scan Corp. DPS Class II 1982-04-21
K820452 PHONOTRACE 2000 Lowrance Electronics, Inc. DXH Class II 1982-04-16
K820487 IMPLANTIBLE SUTURE SLEEVE Intermedics, Inc. DTB Class III 1982-04-16
K820935 MODEL 5866-26 LEAD ADAPTER KIT Medtronic Vascular DTD Class II 1982-04-16
K820742 NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100 Nihon Kohden America, Inc. DPW Class II 1982-04-15
K820864 NORTON MANIFOLD Norton Performance Plastics Corp. DTL Class II 1982-04-15
K820825 CARDIAC MONITOR - RATE ALARM Hewlett-Packard Co. DRT Class II 1982-04-15
K820516 ARTERIAL CANALIZATION DEVICE Alimed, Inc. DQY Class II 1982-04-15
K820477 ALGORITHM OF THE ARRHYTHMIA MON. SYS Hewlett-Packard Co. DSI Class II 1982-04-15
K820736 CENTRAL VENOUS ACCESS CATHETER Hemed, Inc. DQY Class II 1982-04-15
K813223 DISPOSABLE PLASTIC SYRINGE W/NEEDLE Sam Joo Industrial Co., Ltd. DXG Class II 1982-04-15
K820657 PULSE GENERATOR 678 B Siemens Elema AB DXY Class III 1982-04-15
K820834 PERCOR PERCUTANEOUS INTRODUCER Datascope Corp. DYB Class II 1982-04-14
K820828 SAMM Dart Medical Equipment DXH Class II 1982-04-14
K820648 ARROW M.I.S. MULTI-LUMEN CATHETERIZA Arrow Intl., Inc. DQY Class II 1982-04-14

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