meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
1981-01-13

Clearances · page 181 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K803057 FOGARTY BALLON ANGIOPLASTY CATHETERS American Edwards Laboratories LIT Class II 1981-01-13
K803096 NARCO TELECARE TRANSDUCER DOME #700-4000 Narco Scientific DRS Class II 1981-01-13
K803223 ADVANCMED ELIMINATOR American Edwards Laboratories DRT Class II 1981-01-13
K801601 DATASCOPE/AVCO CONNECTOR Datascope Corp. DSP Class II 1981-01-13
K802167 PERCOR DATASCOPE INTRA-AORTIC BALLOON Datascope Corp. DSP Class II 1981-01-13
K803225 ADVANCEMED EXAMINER American Edwards Laboratories DSF Class I 1981-01-13
K803229 4-CHANNEL ECG TELEMETRY MON. SYST. #3045 Cambridge Instruments, Inc. DRG Class II 1981-01-13
K803224 ADVANCEMED HOLTER RECORDERS American Edwards Laboratories DSH Class II 1981-01-13
K803277 TYGON TUBING Electromedics, Inc. DWE Class II 1981-01-13
K803222 ADVANCEMED CCU DOCUMENTOR American Edwards Laboratories DSH Class II 1981-01-13
K801338 CYBERLITH PROGRAMMER Intermedics, Inc. DXY Class III 1981-01-07
K802952 MODEL HEC-7 HEART EVALUATION COMPUTER Kluwe Corp. DPS Class II 1981-01-07
K802312 CC101 ECG MONITORING SYSTEM Anthro-Metrics Corp. DSI Class II 1981-01-07
K802755 ARTERIAL BLOOD FILTER BF-37 Delta Medical Industries DTM Class II 1981-01-07
K802413 IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS Telectronics, Inc. DTB Class III 1981-01-02
K801253 CREST ELECTRONIC WARMING BLANKET Penlon, Inc. DWJ Class II 1981-01-02
K801799 ATRIAL/VENTRICULAR SEQENTIAL #080-20000 Medical Testing System, Inc. LDF Class II 1981-01-02
K801802 ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE Medical Testing System, Inc. DPW Class II 1981-01-02
K802961 TRANSDUCER DOME, CAT.#SD-101 Sorensen Research DRQ Class II 1980-12-31
K803011 DISPOSABLE DIAPHRAGM DONE Sorensen Research DRQ Class II 1980-12-31
K803002 ELECATH FLUID-DRAIN ASSEMBLY Electro-Catheter Corp. DQR Class II 1980-12-22
K803034 MICROTHIN-PII BIPOLAR PULSE GEN. #0623 Cardiac Pacemakers, Inc. DXY Class III 1980-12-22
K803035 MICROTHIN-PII BIPOLAR PULSE GEN. #0621 Cardiac Pacemakers, Inc. DXY Class III 1980-12-22
K803042 SIEMENS-ELEMA ENDOCARDIAL LEAD 402S Siemens Elema AB DTB Class III 1980-12-22
K803102 ARTERIAL BUBBLE TRAP K-20 Delta Medical Industries KRL Class II 1980-12-22
K803101 PREBYPASS FILTER CAT.#K-5 Delta Medical Industries KRJ Class II 1980-12-22
K803059 INTERSEPT* VENOUS RESERVOIR BAG & HOLDER Extracorporeal Medical Specialities, Inc. DTN Class II 1980-12-22
K802353 MICRO THIN-PII, #0523 Cardiac Pacemakers, Inc. DXY Class III 1980-12-22
K802352 MICRO THIN-DII, #0521 Cardiac Pacemakers, Inc. DXY Class III 1980-12-22
K802968 UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC Telectronics, Inc. DTB Class III 1980-12-22
K802945 PRESSURE MONITORING SET Norton Performance Plastics Corp. DQO Class II 1980-12-19
K802925 6-415 FILTER, ELEMENT, 170-C Lifecare Services, Inc. DSK Class II 1980-12-19
K802879 BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL. Shiley, Inc. DTR Class II 1980-12-19
K802529 PFIZONIC 100 ULTRASOUND SCANNER Pfizer Medical Systems, Inc. DXK Class II 1980-12-18
K800746 UNIFOCAL VP, MODELS 7501 AND 7502 American Pacemaker Corp. DXY Class III 1980-12-16
K802849 TECNOL TELEMETRY UNIT POUCH Tecnol New Jersey Wound Care, Inc. DRG Class II 1980-12-16
K802906 WILLIAM HARVEY OXYGENATING GAS FILTER C.R. Bard, Inc. KRI Class I 1980-12-16
K802719 SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S Bentley Laboratories, Inc. DTZ Class II 1980-12-16
K801879 PUIG MASSANA-SHILEY ANNULOPLASTY RING Shiley, Inc. KRH Class II 1980-12-16
K802411 BLOOD PRESSURE UNIT MODEL 310 Js & A Group DXN Class II 1980-12-16
K802412 BLOOD PRESSURE UNIT MODEL 410 Js & A Group DXN Class II 1980-12-16
K802720 SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S Bentley Laboratories, Inc. DTZ Class II 1980-12-16
K802848 CARDIOPLEGIA COOLING SYST. CCAS-2 Bentley Laboratories, Inc. DTR Class II 1980-12-11
K802830 MILLAR MIKRO-TIP CATHETER PHONOTRANS Millar Instruments, Inc. DXW Class II 1980-12-10
K801172 INTERMEDICS' LIFELINE TLE ENDOCARDIAL Intermedics, Inc. DTB Class III 1980-12-01
K801284 LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) Medtronic Vascular DTB Class III 1980-12-01
K801324 SIEMENS-ELEMA PULSE GENERATOR 668 Siemens Elema AB DXY Class III 1980-12-01
K802714 COBE/STOCKERT BATTERY MODULE Cobe Laboratories, Inc. DWB Class II 1980-11-26
K802686 HP MODEL 8880A FILTER Hewlett-Packard Co. DRR Class II 1980-11-26
K802670 CONTIUOUS WAVE DOPPLER ULTRASOUND American Edwards Laboratories DXK Class II 1980-11-26
K802718 MODEL 4700A ELECTROCARDIOGRAPH Hewlett-Packard Co. DPS Class II 1980-11-26
K802316 PDS THERMAL DILUTION CARDIAC MODULE(OUT) General Electric Co. DXG Class II 1980-11-26
K802472 BIOMETRIC ERG SYSTEM Biometric Analysis Group, Inc. DSI Class II 1980-11-26
K802800 NARCO AIR-SHEILDS SYS. 100 MONITOR SYS Narco Air-Shields DXG Class II 1980-11-24
K802287 RIGHT ATRIAL LINE KIT Stanco Medical, Inc. DQY Class II 1980-11-20
K802288 SWAN GANZ CATHETER PLACEMENT KIT Stanco Medical, Inc. DYG Class II 1980-11-20
K802221 CHRONOCOR IV MODEL 250 Cordis Corp. DTE Class II 1980-11-19
K801947 CPR TRAVELER Cardia Concepts Corp. DRM Class II 1980-11-19
K801946 CPR HELPER Cardia Concepts Corp. DRM Class II 1980-11-19
K802782 THE CRITERION II PACING SYS. MONITOR Dart Medical Equipment DRT Class II 1980-11-19
K801945 SAVE MOR Cardia Concepts Corp. DRM Class II 1980-11-19
K802588 MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. Arco Medical Products Co. DXY Class III 1980-11-19
K802058 MAPPING PROBE MODEL #6540 Cardiac Pacemakers, Inc. DRF Class II 1980-11-19
K792609 LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. Medcor, Inc. DXY Class III 1980-11-19
K802476 CARDIACINDEX COMPUTER MODEL SP 1435 Gould, Inc. DXG Class II 1980-11-19
K800870 MEDTRONIC MODEL 6958 Medtronic Vascular DTB Class III 1980-11-13
K802576 EXTERNAL JUGULAR CVP CATHERIZATION KIT Willson DRX Class II 1980-11-12
K802179 CARDIOSCOPE J200 Telectronics, Inc. DRS Class II 1980-11-12
K802602 L-3 PURGE LINE Delta Medical Industries DTM Class II 1980-11-12
K802191 ATGM MODEL AT-80 Herald of America, Inc. DXN Class II 1980-11-12
K802473 BENZALKONIUM-HEPARIN COATED GUIDEWIRES Medrad, Inc. DQX Class II 1980-11-12
K802564 MEDICAL MAGNETIC TAPE RECORDER Medical Concepts, Inc. DSH Class II 1980-11-12
K802600 AMP PORTABLE PATIENT PRESSURE MONITOR American Medical Products, Inc. DSK Class II 1980-11-12
K802293 POLYFLEX IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1980-10-31
K802409 MICROTHIN-DI BIPOLAR PULSE GENERATOR Cardiac Pacemakers, Inc. DXY Class III 1980-10-31
K801055 COMPUPACE, 524-01 PACER SYSTEM COMPUTER Intermedics, Inc. DTE Class II 1980-10-31
K802481 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH Waters Assoc., Inc. DYG Class II 1980-10-31
K802410 MICROTHIN-PI BIPOLAR PULSE GENERATOR Cardiac Pacemakers, Inc. DXY Class III 1980-10-31
K802182 WISCONSIN HEART RATE MONITOR Lunar Radiation Corp. DRT Class II 1980-10-31
K802629 STERI-SLEEVE Cordis Corp. DQO Class II 1980-10-31
K801416 PACEPATH MODEL 810 Pacesetter Systems DTB Class III 1980-10-31
K802407 PACEMAKER LEAD ADAPTOR MODEL 431 Pacesetter Systems DTD Class II 1980-10-31
K802077 UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER Cardiac Pacemakers, Inc. DTD Class II 1980-10-23
K802201 SD-700 BLOOD PRESSURE MONITOR Industrial & Biomedical Sensors Corp. DXN Class II 1980-10-23
K802259 TRANSVENOUS PACEMAKER ELECTRODE KIT Stanco Medical, Inc. LDF Class II 1980-10-23
K802190 MODEL 633A THREE CHANNEL STRESS TEST Quinton, Inc. DPS Class II 1980-10-23
K801953 EXTERNAL, TEMP. PORTABLE CARDIAC GENER Telectronics, Inc. DTE Class II 1980-10-23
K802325 CRITERION II PACING SYSTEM MONITORS Dart Medical Equipment DRT Class II 1980-10-23
K802218 SD-900 OSCILLOMETRIC BP MONITOR Industrial & Biomedical Sensors Corp. DXN Class II 1980-10-23
K801417 PACEPATH MODEL 819 Pacesetter Systems DTB Class III 1980-10-23
K801944 MULTICHANNEL TELEMETRY SYSTEM Burdick Corp. DRG Class II 1980-10-23
K801792 IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC. Telectronics, Inc. DTB Class III 1980-10-23
K801455 LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM Pacesetter Systems DTB Class III 1980-10-23
K801800 UNIVERSAL TEMP. PACING ELECT. #080-10000 Medical Testing System, Inc. LDF Class II 1980-10-23
K802202 SD-800 BLOOD PRESSURE MONITOR Industrial & Biomedical Sensors Corp. DXN Class II 1980-10-23
K802326 PRESSURE MONITORING LINES Stanco Medical, Inc. DRI Class I 1980-10-10
K802282 ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON Consolidated Medical Equipment, Inc. DRR Class II 1980-10-10
K802378 QUICK PRIME LINES, #'S BPL-12, BPL-48 & Bentley Laboratories, Inc. DWF Class II 1980-10-10
K802338 TORQUE CONTROL BALLOON CATHETER Cordis Corp. DYG Class II 1980-10-10
K802305 MLC-4200 CARDIAC OUTPUT COMPUTER Nihon Kohden America, Inc. DXG Class II 1980-10-10

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