meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
39
Latest Decision
1982-04-14

Clearances · page 176 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K820579 FLEX-E1 ECG ELECTRODE Conmedcorp DRS Class II 1982-04-14
K820699 CATHETER GUIDE WIRE Quest Medical, Inc. DQX Class II 1982-04-09
K820774 IMPLANTABLE, MULTIPROGRAMMABLE Biotronik Sales, Inc. DXY Class III 1982-04-09
K820410 HEMOTEC HEPCON/SYSTEM FOUR & FOUR P Hemotec, Inc. LOX Class II 1982-04-09
K820232 TRANSTHORACIC TEMP. PACEMAKER #100TPE Trans Pace, Inc. LDF Class II 1982-04-09
K820767 BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 Siemens Elema AB DTB Class III 1982-04-09
K820853 QUANTUM MODELS 253-09, 254-09 254-10 Intermedics, Inc. DXY Class III 1982-04-09
K820745 DIASCOPE 2 Puritan Bennett Corp. DRT Class II 1982-04-01
K820710 NEONATAL INTRODUCER KIT Norton Performance Plastics Corp. DYB Class II 1982-04-01
K813522 AUTOMATED BLOOD PRESSURE SPHYGMOMANOMTR Vitar DXN Class II 1982-04-01
K820671 CM10 CENTRAL MONITORING SYSTEM Medtel Pty. , Ltd. DRT Class II 1982-04-01
K820540 OLLI 565 Kone Instruments, Inc. DRT Class II 1982-04-01
K813182 DATASCOPE MODIFIED #82 IABP SYSTEM Datascope Corp. DSP Class II 1982-03-31
K820003 CARDIOVASCULAR TEMP. PACEMAKER ELEC Diag Corp. LDF Class II 1982-03-26
K820268 ADAPTAID TEMP. PACING EXT. LEAD #366-02 Intermedics, Inc. DSA Class II 1982-03-26
K820674 OPTICATH Oximetrix, Inc. DQE Class II 1982-03-25
K820677 TOUCH FLUSH CONTINUOUS FAST/FLUSH Norton Performance Plastics Corp. DRS Class II 1982-03-25
K820646 ATRAC TM MULTIPURPOSE BALLOON CATHETER Atrium Medical Corp. DXE Class II 1982-03-25
K820676 TOUCH FLUSH W/Y TRANSDUCER CONNECTOR Norton Performance Plastics Corp. DRS Class II 1982-03-25
K820300 ELECTRONIC DIGITAL SPHYGMOMANOMETER Copal, Inc. DXN Class II 1982-03-25
K820399 HS20 PORT. OPERATING ROOM MONITOR Medtel Pty. , Ltd. DRT Class II 1982-03-22
K820581 NORTON JUGULAR KITS Norton Performance Plastics Corp. DYB Class II 1982-03-18
K812049 STOCKERT CARDIAC PACING ELECTRODES Stoeckert Instrumente DTB Class III 1982-03-18
K820569 IVAC #1160 MULTIPLE VITAL SIGNS UNIT Y DXN Class II 1982-03-18
K820356 MULTICOR (GAMMA) 402 CARDIAC PACER Cordis Corp. DXY Class III 1982-03-18
K813521 TRANSLUMINAL BIPOLAR PACING PROBE American Edwards Laboratories LDF Class II 1982-03-15
K820539 RELIEVED REINFORCED CUP Biomet, Inc. DXQ Class II 1982-03-15
K820231 COMMAND ULTRA I Cardiac Pacemakers, Inc. DXY Class III 1982-03-15
K820230 PACEMAKER PROGRAMMER 2030 Cardiac Pacemakers, Inc. KRG Class III 1982-03-15
K820472 WILLIAM HARVEY H-625 ARTERIAL FILTER C.R. Bard, Inc. DTM Class II 1982-03-15
K820272 CLINIFLOW II, #701, ELECTROMAGN. BLD. SY Carolina Medical Electronics DPW Class II 1982-03-12
K820402 PATIENT FOLLOW-UP COMPUTER (PFC Medical Systems, Inc. DXN Class II 1982-03-12
K820297 WM. HARVEY OVERPRESSURE SAFETY VALVE C.R. Bard, Inc. DTL Class II 1982-03-12
K820457 MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS Graphic Controls Corp. DRS Class II 1982-03-12
K820262 PERMANENT & TEMPORARY PACEMAKER ELECTR. Diag Corp. DTB Class III 1982-03-12
K820342 PHYSIOLOGICAL PRESSURE TRANSDUCER #900 Bentley Laboratories, Inc. DRS Class II 1982-03-04
K820417 #506 PORT. VITAL FUNCTIONS NEONATAL MON Ge Medical Systems Information Technologies DRT Class II 1982-03-04
K820242 DIGICUFF Novatec, Inc. DXN Class II 1982-03-04
K820416 #505 PORT. VITAL FUNCTIONS NEONATAL MON Ge Medical Systems Information Technologies DRT Class II 1982-03-04
K820355 DISPOSABLE DIAPHRAGM DOMES Medex, Inc. DRS Class II 1982-03-04
K820406 TMO INTEGRATED CIRCUIT SYSTEM Travenol Laboratories, S.A. KRI Class I 1982-03-02
K820145 ALLTEK BROMPTON ENCODER Alltek Hospital Supplies , Ltd. DXK Class II 1982-03-02
K820258 DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH Howmedica Corp. DWS Class I 1982-03-02
K813002 MAVIS C Philips Medical Systems (Cleveland), Inc. DXK Class II 1982-03-01
K820135 TAYLOR & TYCOS ACOUSTIC SPHYGMOMANOMETER Sybron Corp. DXN Class II 1982-03-01
K820122 PIONEER II BACK PLATE ELECTRODE Life Science Instrumentation, Inc. DRX Class II 1982-03-01
K820067 ELECTROENCEPHALOGRAPH ECG-6151 Nihon Kohden America, Inc. DPS Class II 1982-02-12
K813246 MEDICAL MULTILITH PULSE GENERA-1140 Ela Medical, Inc. DXY Class III 1982-02-12
K820110 BIOX III Biox Technology, Inc. DQA Class II 1982-02-12
K820202 CONTINUOUS FLUSH DEVICE/FDI Linton Biomed Corp. DRS Class II 1982-02-12
K820186 BARD CARDIOPULMONARY MONITORING LINES C.R. Bard, Inc. DRS Class II 1982-02-12
K820222 SWAN-GANZ VIP-CATHETER American Edwards Laboratories DYG Class II 1982-02-12
K820201 DISPOS. MONITORING SYS/LI ET AL Linton Biomed Corp. DRS Class II 1982-02-12
K820114 SYSTEM V.HEART RATE/RESPIR. RATE MONIT. Narco Air-Shields DRT Class II 1982-02-12
K820121 LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD. Telectronics, Inc. DTB Class III 1982-02-12
K820229 NORTON FLOW DIRECTED THERMODILUTION CATH Norton Performance Plastics Corp. DYG Class II 1982-02-12
K820276 TELESCAN T-30 Telescan Medical Systems DXH Class II 1982-02-12
K812905 PERMANENT ENDOCARD. UNIPOLAR TINED LEAD Diag Corp. DTB Class III 1982-02-04
K812005 CAPILLARY PERFUSION MONITOR #LD5000 Nuclear Pacific, Inc. DPW Class II 1982-02-04
K813577 PRESSURE INDICATOR-REGULATOR Advanced Catheter Systems DQO Class II 1982-01-29
K813385 DIGITAL BLOOD PRESSURE UNIT Conphar, Inc. DXN Class II 1982-01-29
K820001 CORONARY INFUSION KIT Mallinckrodt Critical Care DQO Class II 1982-01-29
K813266 NIHON KOHDEN ELECTROCARDIOGRAPH Nihon Kohden America, Inc. DRS Class II 1982-01-29
K813602 HOLTER PERFORMER Applied Cardiac Systems DSH Class II 1982-01-29
K820045 CARDIOVASCULAR DEVICES Bentley Laboratories, Inc. DTM Class II 1982-01-29
K820102 SUBCLAVIAN JUGULAR CATHETER SET Luther Medical Products, Inc. DQR Class II 1982-01-29
K820046 ANESTHESIOLOGY DEVICES Bentley Laboratories, Inc. DRS Class II 1982-01-29
K813205 INTERSEPT CARDIOTOMY RESERVOIR/FILTER Extracorporeal Medical Specialities, Inc. DTB Class III 1982-01-28
K813556 MOD. 587 BLOOD PRESSURE & PULSE MONITOR Bio Mega Diagnostic, Inc. DXN Class II 1982-01-22
K813623 SIMPSON-ROBERT CORONARY GUIDING CATHET Advanced Catheter Systems DQO Class II 1982-01-22
K813622 INDEFLATOR Advanced Catheter Systems DQO Class II 1982-01-22
K813302 CONPHAR PALM ANEROID SPHYGMOMANOMETER Conphar, Inc. DXQ Class II 1982-01-22
K813303 CONPHAR, WALL ANEROID SPHYGMOMANOMETER Conphar, Inc. DXQ Class II 1982-01-22
K820011 CARDIOSTRESS Instruments For Cardiac Research DPS Class II 1982-01-22
K820033 CARDIOVUE ACCESSORY CART Diasonics, Inc. DSF Class I 1982-01-22
K813534 COMMAND P5 Cardiac Pacemakers, Inc. DXY Class III 1982-01-22
K813174 BRADYCARDIA ALARM Douglas Scientific Products DRT Class II 1982-01-22
K813624 ADVANCED CATHETER SYSTEMS CORONARY GUID Advanced Catheter Systems DQO Class II 1982-01-22
K813576 SIEMENS-ELEMA PULSE GENERATOR 659 Siemens Elema AB DXY Class III 1982-01-22
K820009 ARROW JUGULAR PUNCTURE KIT 16 GA. Arrow Intl., Inc. DQY Class II 1982-01-22
K813255 LPM/50 MEMBRANE OXYGENATOR Travenol Laboratories, S.A. DTZ Class II 1982-01-18
K812830 APC IMPLANTABLE PACING LEAD American Pacemaker Corp. DTB Class III 1982-01-18
K812793 P.E.T. Hospital Equipment Service DXH Class II 1982-01-18
K813578 HEMOSTATIC SIDE-ARM ADAPTER Advanced Catheter Systems DYG Class II 1982-01-18
K812807 APC IMPLANTABLE PACING LEADS American Pacemaker Corp. DTB Class III 1982-01-18
K813553 PACE *AID Cardiac Resucitator Corp. DRO Class II 1982-01-18
K813527 DINAMAP ADULT/PED./NEONATAL VITAL SIGNS Critikon Company, LLC DXN Class II 1982-01-12
K813510 CARDIOSONIC ACOUSTIC AMPLIFIER Srs Co. LDE Class I 1982-01-12
K813549 CONTINUOUS FLUSH DEVICE Namic DRS Class II 1982-01-12
K813518 IMPLANT AID SPLICING CRIMP & SLEEVE Intermedics, Inc. KFJ Class III 1982-01-12
K813464 DISPOSABLE TRANSDUCER Sorensen Research DRS Class II 1982-01-07
K813498 MEDIFIX Burron Medical Products, Inc. KRK Class II 1982-01-07
K813331 P51 ANGIOPLASTY PRESSURE TRANSDUCER Konigsberg Instruments, Inc. LIT Class II 1981-12-29
K813176 GEL ELECTRODE Dyn-A-Med Products DRX Class II 1981-12-29
K813471 LINE POWERED LOW ENERGY DEFIBRILLATOR II Narco Scientific LDD Class II 1981-12-29
K813064 TELEMETRY TRANSMITTER & RECEIVER Honeywell, Inc. DRG Class II 1981-12-29
K813502 NARCO TELECARE ISOFLO PRESSURE MONITOR Narco Bio-Systems DRS Class II 1981-12-29
K813444 NIHON KOHDEN HEART MONITORS OMP 7101-02 Nihon Kohden America, Inc. DRT Class II 1981-12-29
K813271 TEMPERATURE PROBES Webster Laboratories, Inc. KRI Class I 1981-12-29
K813195 MEDIFIX GRADUATED SCALE Burron Medical Products, Inc. KRK Class II 1981-12-29

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