meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
38
Latest Decision
1985-10-09

Clearances · page 161 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K852181 ELECTROCARDIOGRAPH Armstrong Ind., Inc. DPS Class II 1985-10-09
K852282 SCHILLER MINISCOPE MS-2 EKG SCOPE Armstrong Ind., Inc. DPS Class II 1985-10-09
K852281 SCHILLER EKG COMBI MSG-IM SCOPE & RECORDER Armstrong Ind., Inc. DPS Class II 1985-10-09
K853520 LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD Intermedics, Inc. DTB Class III 1985-10-08
K851517 CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO Circadian, Inc. DSI Class II 1985-10-02
K852708 IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A Telectronics, Inc. DTB Class III 1985-10-01
K853411 MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1985-10-01
K852807 BIO MEDICUS BIO PUMP MODEL BP-50 Bio Medicus, Inc. KFM Class II 1985-09-30
K852698 BIO MEDICUS BIO PUMP MODEL BP-80 Bio Medicus, Inc. KFM Class II 1985-09-30
K852780 BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV) Shiley, Inc. DTR Class II 1985-09-30
K851739 DUNN VESSEL OCCLUDER-STERILE Richard J. Turner Assoc. DXC Class II 1985-09-27
K843905 TRAUMA CARE EVALUATION Quantitative PLB Class II 1985-09-26
K852382 CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR American Bentley DTN Class II 1985-09-25
K853100 COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT Cobe Laboratories, Inc. DYB Class II 1985-09-25
K852900 CVERNE CAD DETECTOR Cherne Industries, Inc. DXG Class II 1985-09-25
K852491 AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER American Pharmaseal Div. Ahsc DQY Class II 1985-09-25
K852914 ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION Norton Performance Plastics Corp. DQY Class II 1985-09-25
K852612 METRONIC MODEL F7700 HEART VALVE SIZERS Medtronic Vascular DTI Class I 1985-09-23
K852543 KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM Kontron Instruments, Inc. DXK Class II 1985-09-20
K852487 FUKUDA DENSHI MODEL AU-5001-5003 THERMAL Fukuda Denshi USA, Inc. DSF Class I 1985-09-19
K852709 IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A Telectronics, Inc. DTB Class III 1985-09-17
K852294 BARD-PARKER OCCLUSION BALLOON CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic DYG Class II 1985-09-17
K852446 ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP Diag Corp. DTB Class III 1985-09-17
K853221 SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD,#30-401 Telectronics, Inc. DTB Class III 1985-09-17
K853222 SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-402 Telectronics, Inc. DTB Class III 1985-09-17
K850677 TELEFLEX GUIDEWIRE Teleflexmedical, Inc. DQX Class II 1985-09-17
K853223 SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, #30-407 Telectronics, Inc. DTB Class III 1985-09-17
K852972 IMPLANTABLE ELECTRODE LEAD, MODEL 030-400 Telectronics, Inc. DTB Class III 1985-09-16
K852808 CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) Cardiac Recorders, Ltd. LDD Class II 1985-09-16
K852799 2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR) Cardiac Recorders, Ltd. LDD Class II 1985-09-16
K852124 HEMATOCRIT-SATURATION MONITOR HSM-100 American Bentley DRY Class II 1985-09-16
K852469 SAF-D-FIB Medtronic Andover Medical, Inc. DRX Class II 1985-09-16
K851913 CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA Cordis Corp. LDF Class II 1985-09-16
K852513 115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD C.R. Bard, Inc. LDF Class II 1985-09-16
K852455 GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 Gambro, Inc. KRI Class I 1985-09-16
K851732 CARBOCONE Imtech Corp. DRX Class II 1985-09-16
K852797 HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE Mansfield Scientific, Inc. LDF Class II 1985-09-16
K852119 TEMPORARY PACEMAKER GROUND WIRE Scholten Surgical Instruments, Inc. DTB Class III 1985-09-15
K853058 NEOS - M ABP Biotronik Sales, Inc. DXY Class III 1985-09-13
K852746 EXTERNAL PACEMAKER TELECTRONICS TE200 Seamed Corp. JOQ Class II 1985-09-12
K852514 MODEL 78560A CENTRAL STATION PATIENT INFO SYS Hewlett-Packard Co. DSI Class II 1985-09-12
K853206 IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW Telectronics, Inc. DXY Class III 1985-09-12
K852128 NORELCO ELECTRONIC DIGITAL BP METER HC3501 Philips Park DXN Class II 1985-09-12
K853057 TRIOS - M Biotronik Sales, Inc. DXY Class III 1985-09-12
K852322 VSM-5 Physio-Control Corp. DPS Class II 1985-09-11
K851643 REMOTE CONTROL MODULE Circadian, Inc. DPS Class II 1985-09-09
K841811 BENTLEY-TRANTEC DISPOS. DOMES D-260- American Bentley DRS Class II 1985-09-09
K851223 COPAL DIGITAL SPHYGMOMANOMETER UA-560 Takeda Medical, Inc. DXN Class II 1985-09-09
K852880 PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) Argon Medical Corp. DYB Class II 1985-08-29
K844814 BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD Intermedics, Inc. DTD Class II 1985-08-29
K851485 DEFI 502 Robert Bosch Corp. LDD Class II 1985-08-29
K851845 NUMED TEMP. STYLET PACING PAROBE 1318694 NuMED, Inc. LDF Class II 1985-08-29
K850968 MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN Medtronic Vascular DTD Class II 1985-08-29
K851731 ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860 Ela Medical, Inc. DTB Class III 1985-08-29
K852815 TRIPLE LUMEN RIGHT ATRIAL CATHETER Quinton, Inc. DQY Class II 1985-08-26
K852388 MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT Quinton, Inc. DQY Class II 1985-08-22
K850482 DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO Datascope Corp. DSP Class II 1985-08-22
K844913 CORDIS PTA CATHETER-PERCUTANEOUS CATHETER Cordis Corp. LIT Class II 1985-08-20
K840717 ECS 502 Robert Bosch Corp. DRT Class II 1985-08-19
K841967 DESERET THERMODILUTION CARDIAC OUTPUT Parke-Davis Co. DXG Class II 1985-08-19
K851916 VSM MODELS A & B Physio-Control Corp. DRT Class II 1985-08-19
K853425 CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR Cardio-Pace Medical, Inc. DXY Class III 1985-08-19
K851989 DOME, DISPOSABLE, STERILE Transamerica Delaval, Inc. DRS Class II 1985-08-19
K852564 COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR Takeda Medical, Inc. DXN Class II 1985-08-19
K851947 PTCA GUIDING CATHETER Cordis Corp. DYB Class II 1985-08-16
K851987 FLUSH DEVICE, AUTOMATIC Transamerica Delaval, Inc. DRS Class II 1985-08-16
K851988 ADMINISTRATION SET Transamerica Delaval, Inc. DRS Class II 1985-08-16
K850137 TECA TC2-64 TRANSCRANIAL DOPPLER Teca, Inc. DPW Class II 1985-08-14
K851323 AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU C.R. Bard, Inc. DWF Class II 1985-08-12
K852232 PRESSURE DISPLAY BOX #60000/TUBING SET #61000 Dlp, Inc. DXS Class II 1985-08-09
K852099 BARD-PARKER IRRIGATION CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic DQY Class II 1985-08-09
K852479 PULMONARY VEIN CLAMP None DXC Class II 1985-08-09
K852086 CAPIOX BLOOD SAMPLING MANIFOLD Terumo Medical Corp. DTL Class II 1985-08-09
K852177 FOAM ECG ELECTRODES Clinical Data, Inc. DRX Class II 1985-08-09
K851897 CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD Cardiac Control Systems, Inc. DTD Class II 1985-08-09
K852356 MEDTRONIC MODEL 5561 Medtronic Vascular DTD Class II 1985-08-06
K851924 LITEGUARD 9 Temtech , Ltd. LDD Class II 1985-08-06
K851888 APM DISPOS. BLOOD PRESSURE TRANSDUCER Honeywell, Inc. DRS Class II 1985-08-06
K852435 CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA Cardiac Control Systems, Inc. DXY Class III 1985-08-06
K844918 OCCLUSION & OCCLUSION-IRRIGATION Clincal Instruments Corp. DQT Class II 1985-08-05
K851406 AJDJUSTABLE SUCTION CONTROL VALVE American Omni Medical, Inc. DWD Class II 1985-08-05
K851854 ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO Advanced Cardiovascular Systems, Inc. LIT Class II 1985-08-05
K851931 DEFI 2 S & W Medico Teknik LDD Class II 1985-08-05
K850952 BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI C.R. Bard, Inc. DYG Class II 1985-08-05
K851465 SILENT GUARD CAT. NO. SG-30 American Omni Medical, Inc. DTL Class II 1985-08-05
K852770 CARIOLINE(ELECTROCARDIOGRAPH) Remco Italia S.P.A. DPS Class II 1985-08-01
K851707 OMRON DIGITAL BP MONITOR HEM-400C Omron Tateisi Electronics Co. DXN Class II 1985-07-31
K852193 POROCOAT SCHATZKER II ACETABULUM Depuy, Inc. DXQ Class II 1985-07-30
K852270 LIFESCOPE 8 DEC-8108A AND DEC-8204A Nihon Kohden America, Inc. DSI Class II 1985-07-30
K851269 DOPLETTE 10 Imex Medical Systems, Inc. JOP Class II 1985-07-29
K852916 SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 Telectronics, Inc. DYB Class II 1985-07-29
K852918 SLIM ART J. BIP PACING LEAD USING POLY #030-2821 Telectronics, Inc. DYB Class II 1985-07-29
K852964 P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION Howmedica Corp. DXQ Class II 1985-07-29
K852917 SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283 Telectronics, Inc. DYB Class II 1985-07-29
K851702 MORTARA INSTRUMENT MODEL EL-1 Mortara Instrument, Inc. DSI Class II 1985-07-29
K852354 WHOLEY HI-TORQUE GUIDE WIRES Advanced Cardiovascular Systems, Inc. DQX Class II 1985-07-29
K851616 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA Ausonics Pty , Ltd. JOP Class II 1985-07-29
K851003 ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX Gish Biomedical, Inc. DTM Class II 1985-07-29
K852915 SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 Telectronics, Inc. DTB Class III 1985-07-29
K852253 329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR Cordis Corp. DTD Class II 1985-07-29

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