meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
41
Latest Decision
1984-08-10

Clearances · page 167 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K842799 PERCUTANEOUS ANGIOSCOPE DELIVERY CATH American Edwards Laboratories DQO Class II 1984-08-10
K842044 SARNS EVACUPLEGE CATHETER 3M Health Care, Sarns DWE Class II 1984-08-10
K842798 INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH American Edwards Laboratories DQO Class II 1984-08-10
K841261 COMPUTER, CENTRAL PROCESSING UNIT Nem Computer Corp. DXG Class II 1984-08-10
K841968 DESERET DISPOSABLE PRESSURE TRANSDUCER Parke-Davis Co. DRS Class II 1984-08-06
K841633 NEOS LP Biotronik Sales, Inc. DXY Class III 1984-08-06
K841521 SCANLAN ENDARSECTOR Scanlan Intl., Inc. DWX Class II 1984-08-03
K834382 PALL EC PLUS FILTER W/FILTER SLEEVE Pall Biomedical Products Co. DTM Class II 1984-08-03
K842007 CENTRIMED SYSTEM 1 Centrimed Corp. KFM Class II 1984-08-03
K841885 FASTPASS IMPLANTABLE ENDOCARDIAL PAC Pacesetter Systems DTD Class II 1984-08-03
K840440 ELECTROCARDIOGRAPH E-340 Burdick Corp. DPS Class II 1984-08-03
K842005 MODEL 110-5 & 140-8 Camino Laboratories, Inc. DXO Class II 1984-08-03
K842780 MEDTRONIC 6210 PERMANENT LEAD INTRODUC Medtronic Vascular DYB Class II 1984-08-03
K841635 LEPTOS Biotronik Sales, Inc. DXY Class III 1984-08-03
K842138 COBE EMERGENCY POWER SOURCE 43610-000 Cobe Laboratories, Inc. DTQ Class II 1984-08-03
K842141 SOLUTION CLARIFICATION UNIT Pall Biomedical Products Co. KRJ Class II 1984-08-03
K842321 AIR SHIELDS AS461 MONITORING SYS Air-Shields, Inc. DRT Class II 1984-08-03
K840198 ARTERIAL EMBOLECTOMY CATHETER Shiley, Inc. DXE Class II 1984-08-03
K834380 PALL EC PLUS FILTER Pall Biomedical Products Co. DTM Class II 1984-08-03
K841476 TUBULAR HOLLOW FIBER MEMBRANE American Bentley DTZ Class II 1984-08-03
K841739 MODEL 866 PERMATHANE BIPOLAR, COAXIAL Pacesetter Systems DTD Class II 1984-08-03
K840748 LITHIUM PACEMAKER 811-811L & 811XL Omikron Scientific, Ltd. DXY Class III 1984-08-03
K841938 CARDIOPLEGIA RESERVOIR CAS-2000 American Bentley DTN Class II 1984-08-03
K842054 COBE AEPS Cobe Laboratories, Inc. KRL Class II 1984-08-02
K841611 QUINTON 901 & 900 HOLTER SCANNER Quinton, Inc. DPS Class II 1984-08-02
K842259 PCI W/CATH-SEAL SIDE FLOW FITTING Universal Medical Instrument Corp. DYB Class II 1984-08-01
K842084 AXIOM FEMORAL VENUS CATHETER Axiom Medical, Inc. DQY Class II 1984-08-01
K841172 MONITOR ONE Qmed, Inc. DSI Class II 1984-07-27
K841822 KEYMED SIGMOIDOSCOPE SUCTION UNIT Keymed, Inc. DRM Class II 1984-07-27
K842316 CRITIKON TRIPLE-LUMEN CENTRAL VENOUS Critikon Company, LLC DQY Class II 1984-07-20
K840542 MINI-DOPPLER ES-100 Hayashi Denki Co., Ltd. JOP Class II 1984-07-16
K842195 ADVANCED CARDIOVASCULAR-CORONARY GUID Advanced Cardiovascular Systems, Inc. DQO Class II 1984-07-13
K841705 WEDGE PRESSURE CATHETER FLOW DIRECTED Mansfield Scientific, Inc. DYG Class II 1984-07-13
K840762 SILVERTORQUE CEREBRAL CATHETER Surgimed Corp. DQY Class II 1984-07-13
K842176 RAAF DUAL LUMEN CATHETER Quinton, Inc. DQY Class II 1984-07-13
K841828 CENTRAL VENOUS CATHETER W/BIG-GARD Norton Performance Plastics Corp. DQY Class II 1984-07-13
K841876 POLYURETHANE THERMAL DILUTION CATHET Waters Instruments, Inc. DYG Class II 1984-07-13
K842004 PERCUTANEOUS CATHETER INTRODUCER SET Aries Medical, Inc. DYB Class II 1984-07-13
K842113 AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT Mallinckrodt Critical Care DRE Class II 1984-07-13
K841928 COOK PACEMAKER 215 UNIPOLAR CARDIAC- Cook Pacemaker Corp. DXY Class III 1984-07-11
K841983 COOK PACEMAKER 216 BIPOLAR CARDIAC - Cook Pacemaker Corp. DXY Class III 1984-07-11
K841233 PULSE GENERATOR 678L Siemens Elema AB DXY Class III 1984-07-06
K840875 MULTIVARIATE DIGITAL CARDIOGRAPH Clinical Microsystems Intl. DQK Class II 1984-07-06
K841605 BP TRAUMA AIR PANTS Bp Medical Systems, Inc. LHX Class II 1984-07-06
K842081 COOK PACEMAKER CORP. 115 UNIPOLAR CARDI Cook Pacemaker Corp. DXY Class III 1984-07-06
K841995 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK Quinton, Inc. DRE Class II 1984-07-02
K840622 CARDIO EXPRESS 100 HOLTER SCANNER Del Mar Avionics DSI Class II 1984-07-02
K840795 ACS SOF-T GUIDE WIREE Advanced Cardiovascular Systems, Inc. DQT Class II 1984-07-02
K841228 PULSE GENERATOR 718B & 718L Siemens Elema AB DXY Class III 1984-06-26
K841231 PULSE GENERATOR 688B & 688L Siemens Elema AB DXY Class III 1984-06-26
K841226 PULSE GENERATOR 728, 728B & 728L Siemens Elema AB DXY Class III 1984-06-26
K841636 NEOS M Biotronik Sales, Inc. DXY Class III 1984-06-25
K841950 PULSE GENERATOR KALOS-04 Biotronik Sales, Inc. DXY Class III 1984-06-25
K841229 PULSE GENERATOR 698, 698B & 698L Siemens Elema AB DXY Class III 1984-06-25
K840023 TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC American Bentley DRS Class II 1984-06-22
K840465 Q-MED ELECTRODE Qmed, Inc. DRX Class II 1984-06-19
K840909 AUTOMATED NON-INVASIVE PRESSURE MODULE Gould, Inc. DXN Class II 1984-06-15
K841381 DIGITAL SPHYGMOMANOMETER UA-273 Promedical Industries, Inc. DXN Class II 1984-06-14
K841380 DIGITAL SPHYGMOMANOMETER UA-254 Promedical Industries, Inc. DXN Class II 1984-06-14
K840763 SILVERTORQUE CARDIAC CATHETERS Surgimed Corp. DQO Class II 1984-06-13
K841587 CENTRAL VENOUS ACCESS CATHETER CVAC-XX Gish Biomedical, Inc. DQY Class II 1984-06-13
K840900 PORTA PAK 90 Medical Research Laboratories, Inc. LDD Class II 1984-06-11
K840761 SILVERTORQUE VISCERAL CATHETER Surgimed Corp. DQY Class II 1984-06-11
K841812 HOLDER FOR BOS-10, 10S 5S American Bentley KRI Class I 1984-06-11
K841493 MODEL 1000 APC-ANGIOPLASTY PRESSURE E.A. Fischione Instrument Mfg. DXT Class II 1984-06-11
K841317 DESERET HEPARIN COATED FLOW DIRECTED Parke-Davis Co. DYG Class II 1984-06-11
K833873 CARDIOSEARCH RIGHT ATRIAL CATH- Cardio Search, Inc. DQY Class II 1984-06-11
K841296 TUBE TENDER The Anspach Effort, Inc. KRI Class I 1984-06-11
K841482 PRESSURE CATHETER PLACEMENT SET 50010 Dlp, Inc. DWF Class II 1984-06-11
K841251 DESERET HEPARIN COATED FLOW CATH Parke-Davis Co. DYG Class II 1984-06-11
K841402 TEMPERATURE CONTROL & MONITOR Sams, Inc. DWC Class II 1984-06-11
K841468 PMA ANGIOGRAPHY TRAY Professional Medical Services DWS Class I 1984-06-05
K834211 LEAP FROG Philips Medical Systems (Cleveland), Inc. DSI Class II 1984-06-05
K841616 TIMEX HEALTHCHECK DIGITAL BP MONITOR Timex Medical Products Corp. DXN Class II 1984-06-05
K841615 ELECATH HEPARIN-COATED CATHETERS Electro-Catheter Corp. DQO Class II 1984-06-05
K840521 SERVOMED DIGITAL DISPLAY MODULE Litton Medical Electronics DRT Class II 1984-06-01
K833000 I-CHANNEL RECORDER Litton Medical Electronics DSF Class I 1984-06-01
K834530 EXTENSION BOX EB200 Honeywell, Inc. DRT Class II 1984-06-01
K834600 RECOMB ECG PREAMPLIFIER/206 069 03 Litton Medical Electronics DRT Class II 1984-06-01
K832998 2-CHANNEL RECORDER Litton Medical Electronics DSF Class I 1984-06-01
K832250 SERVOMED BASIC BEDSIDE UNIT SMA 102- Litton Medical Electronics DRT Class II 1984-06-01
K840525 SERVOMED COMPACT MONITOR SMK 155-1/101 Litton Medical Electronics DRT Class II 1984-06-01
K840262 HANCOCK PERICARDIAL PATCH Extracorporeal Medical Specialities, Inc. DXZ Class II 1984-05-30
K841404 PRIMA 236-02 NONPROGRAMMABLE CARDIAC Intermedics, Inc. DXY Class III 1984-05-30
K840162 DRAGER SPHYGMOMED Draeger Medical, Inc. DXN Class II 1984-05-30
K841031 OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT American Bentley DTN Class II 1984-05-23
K840824 HEPARIN COATED THERMODILUTION CATHETERS Gould, Inc. KRB Class II 1984-05-23
K840026 IMPLANTABLE ELECTRODE UNIPOLAR ADAPT Telectronics, Inc. DTD Class II 1984-05-23
K834525 ANGIOSCAN FLO MAD SPECTRUM ANALYZER Unigon Industries, Inc. JOP Class II 1984-05-23
K840992 THERMODILUTION CATHETER Gould, Inc. KRB Class II 1984-05-23
K840025 IMPLANTABLE ELECTRODE BIPOLAR ADAPT Telectronics, Inc. DTD Class II 1984-05-23
K840258 TEC-3500 DEFIBRILLATOR Nihon Kohden America, Inc. LDD Class II 1984-05-23
K832903 ESOPHOGRAL MULTIPROBE Vital Signs, Inc. DRX Class II 1984-05-23
K840455 EMERGENCY INFUSION DEVICE Arrow Intl., Inc. DYB Class II 1984-05-23
K833627 CIRCULATOR MINIBOOT Circulator Boot Corp. DRN Class II 1984-05-23
K834441 BLOOD PRESSURE MONITOR BP600X Lifeline Systems, Inc. DXN Class II 1984-05-21
K840469 TYCOS SELF CHECK BPM3 BLOOD PRESS MONI Sybron Corp. DXN Class II 1984-05-21
K833632 ARIES MEDICAL MODEL 700 Aries Medical, Inc. DSP Class II 1984-05-16
K840121 PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C Hewlett-Packard Co. DRS Class II 1984-05-16
K841075 CARCIAC PULSE GENERATOR 254-20 Intermedics, Inc. DXY Class III 1984-05-16

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