meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
49
Latest Decision
1987-11-20

Clearances · page 151 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K872983 TORAY ANTHRON ANGIOGRAPHIC CATHETERS Toray Industries (America), Inc. DQR Class II 1987-11-20
K873081 EDENTEC MULTI-CHANNEL RECORDER Edentec Corp. DQA Class II 1987-11-17
K870857 ABCOM 1 CARDIAC OUTPUT MONITOR Applied Biometrics, Inc. JOP Class II 1987-11-16
K873597 TUBING, POLYETHYLENE Coeur Laboratories, Inc. DXT Class II 1987-11-12
K873774 M300 MONITOR/CONTROLLER T500 TREADMILL Burdick Corp. DXJ Class II 1987-11-06
K870885 MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD Medtronic Vascular DTB Class III 1987-11-06
K873212 SARNS CARDIOPLEGIA/VENT CATHETERS 3M Health Care, Sarns DWF Class II 1987-11-06
K871697 GENESIS II Biosound, Inc. DXK Class II 1987-11-06
K873802 PRESSURE BARRIER KIT CAT. NO. PBK-3 American Omni Medical, Inc. DXS Class II 1987-11-06
K873813 SARNS WARMER, PART #164975 AND #164980 3M Health Care, Sarns DWC Class II 1987-11-06
K873745 BAIR HUGGER(TM) - PATIENT WARMING SYSTEM Augustine Medical, Inc. DWJ Class II 1987-11-06
K873423 MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER Johnson & Johnson Professionals, Inc. DTN Class II 1987-11-06
K873923 INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER American Bentley DTZ Class II 1987-11-06
K873561 ELECTROMEDICS D1079E Electromedics, Inc. DTR Class II 1987-11-05
K874117 MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE Medtronic Vascular DYG Class II 1987-11-05
K872837 EPICARIDA, LE Medicomp, Inc. DSI Class II 1987-11-04
K862947 THE EXPERT MODELS RTS 2000 AND RTS 2000H Ocg Technology, Inc. DSI Class II 1987-11-04
K872778 PACESTART Pacific Rim Engineering & Mfg. DRO Class II 1987-11-04
K872822 MODEL 78576A PAPER CHART RECORDER Hewlett-Packard Co. DSF Class I 1987-11-04
K872766 IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS Telectronics, Inc. DXY Class III 1987-11-04
K872779 PROLOG MP PULSE GENERATORS 658K AND 658T Pacesetter Systems DXY Class III 1987-11-04
K872869 STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) Labeltape Meditect, Inc. DXH Class II 1987-11-04
K873728 DEKNATEL TEMPORARY CARDIAC PACING WIRE Deknatel, Inc. LDF Class II 1987-11-03
K872090 THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT Ideas For Medicine, Inc. DQT Class II 1987-10-30
K872163 IMPRA DUAL LUMEN SUBCLAVIAN CATHETER Impra, Inc. DQY Class II 1987-10-30
K872182 POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE Polystan C/O Vitalcor, Inc. DQY Class II 1987-10-30
K873065 MODEL 7200A WITH PULSE OXIMETRY Puritan Bennett Corp. DQA Class II 1987-10-26
K873584 MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR Quinton, Inc. DPS Class II 1987-10-26
K873931 MODIFIED MODELS 1025M & 1026T PACING LEAD Pacesetter Systems DTB Class III 1987-10-22
K870726 RT5000 ECHOCARDIOGRAPHY #H4100C/CE General Electric Co. JOP Class II 1987-10-20
K872981 ACS INDEFLATOR PLUS (MODIFICATION #2) Advanced Cardiovascular Systems, Inc. DXT Class II 1987-10-20
K871344 PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR Reynolds Medical , Ltd. DSI Class II 1987-10-20
K872871 NEONATAL SPUNLACE BREATHABLE POLY. FABRIC ECG(RCR) Labeltape Meditect, Inc. DRX Class II 1987-10-16
K873202 VICOR, MODEL 410A Tpl-Cordis, Inc. DXY Class III 1987-10-15
K872770 DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. Nova Medical Specialties DYG Class II 1987-10-15
K872793 DP-700 NIKMAN DEFIB-PADS Nikomed U.S.A., Inc. LDD Class II 1987-10-09
K872231 BARD EPICARDIAL ELECTRODE ARRAY C.R. Bard, Inc. DRF Class II 1987-10-09
K873765 FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER Nam Tai , Ltd. DSK Class II 1987-10-09
K873337 MODEL SSR1 HOLTER MONITOR Cardiodata Corp. DSH Class II 1987-10-09
K872784 MACTRODE-II Marquette Electronics, Inc. DRX Class II 1987-10-09
K873687 ANGIOMAT CT INJECTOR Mallinckrodt Group, Inc. DXT Class II 1987-10-09
K873528 MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS Intermedics, Inc. DXY Class III 1987-10-09
K873492 BSK-1033 TELEMETRY MONITORING CABLE Desco Industries, Inc. DSA Class II 1987-10-09
K872772 OHMEDA BIOX 3740 PULSE OXIMETER Ohmeda Medical DQA Class II 1987-10-07
K873346 MODEL 2240 SLAVE SCOPE Marquette Electronics, Inc. DPS Class II 1987-10-07
K873474 SUTURELESS TEMPORARY EPICARDIAL PACING LEAD Symbion, Inc. LDF Class II 1987-10-07
K873727 PULL-APART INTRODUCER (SHEATH) Quinton, Inc. DYB Class II 1987-10-07
K873488 SILENT GUARD CAT. NO. SG-10 American Omni Medical, Inc. DTL Class II 1987-10-07
K863857 PULSE-OX Life Design Systems, Inc. DQA Class II 1987-10-07
K872497 MODEL MR-45 AMBULATORY HOLTER MONITOR Oxford Medilog, Inc. DSI Class II 1987-10-06
K873716 ADULT WALKING HEEL PRODUCT NO. 4183-130 Martin Medical LDF Class II 1987-10-02
K872517 TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM D. E. Hokanson, Inc. JOM Class II 1987-10-01
K872043 CHURCHILL INTER-CARDIAC SUCKER Churchill Corp. DWF Class II 1987-09-30
K872241 LIFESCOPE 12, BSM 8500A PATIENT MONITOR Nihon Kohden America, Inc. DSI Class II 1987-09-30
K871727 MODIFIED RADIUS - MODEL NUMBER MM 5000 Ultrasonix, Inc. JOP Class II 1987-09-30
K872719 EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER Shiley, Inc. DTN Class II 1987-09-30
K872596 TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 American Edwards Laboratories DRS Class II 1987-09-30
K872068 HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD Advanced Technology Laboratories, Inc. DPW Class II 1987-09-30
K873206 MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE Respiratory Support Products, Inc. DTW Class II 1987-09-30
K873394 OVAL PULL-APART SHEATH/DILATOR Quinton, Inc. DYB Class II 1987-09-30
K871506 ACUSON L538 TRANSDUCER Acuson Computed Sonography JOP Class II 1987-09-28
K871416 AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER Acuson Computed Sonography JOP Class II 1987-09-28
K862970 TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 Medtronic Vascular LDF Class II 1987-09-25
K872291 ESCORT PORTABLE PATIENT MONITOR Medical Data Electronics DXO Class II 1987-09-25
K872788 MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN Uresil Corp. DWF Class II 1987-09-25
K873035 VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER Gish Biomedical, Inc. DQY Class II 1987-09-25
K872508 MODEL MICRO FD+ AMBULATORY ECG MONITOR Advanced Medical Products, Inc. DSH Class II 1987-09-25
K871369 VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: Keeler Instruments, Inc. LDE Class I 1987-09-24
K872762 TORAY ANTHRON AORTA BYPASS TUBES Toray Industries (America), Inc. DWF Class II 1987-09-24
K873078 NOVAMETRIX MODEL 505 PULSE OXIMETER Novametrix Medical Systems, Inc. DQA Class II 1987-09-23
K872720 SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET Shiley, Inc. DTN Class II 1987-09-23
K872721 EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR Shiley, Inc. DTN Class II 1987-09-23
K872722 EXPANDED USE FOR SHILEY 3L CARDF PLUS Shiley, Inc. DTN Class II 1987-09-23
K872476 REPLACEMENT BATTERIES FOR MEDICAL INSTRUMENTATION Energy Concepts, Inc. MHX Class II 1987-09-21
K872034 CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM Cardiomedics, Inc. DRN Class II 1987-09-18
K872368 MODIFIED VERSA STIM ELECTRODE LINE Conmedcorp DRO Class II 1987-09-18
K871573 CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS Spectramed, Inc. DQY Class II 1987-09-16
K872529 THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 American Edwards Laboratories DXG Class II 1987-09-15
K871882 LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW) Lake Region Mfg., Inc. DQX Class II 1987-09-15
K872724 SHEATH/DILATORS Med-West, Inc. DRE Class II 1987-09-15
K872629 TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER/ UA-741 A&D Engineering, Inc. DXN Class II 1987-09-15
K873004 GUIDING CATHETER Mallinckrodt Critical Care DQO Class II 1987-09-15
K871271 HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR. Huntleigh Technology, Inc. DRM Class II 1987-09-15
K872355 COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470 Colin Medical Instruments Corp. DXN Class II 1987-09-15
K872731 PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860 Ela Medical, Inc. DTB Class III 1987-09-15
K872790 PERFUSION CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic DQT Class II 1987-09-15
K872626 OXIMETRY MODULE Marquette Electronics, Inc. DQA Class II 1987-09-15
K872472 SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICE Angiomedics, Inc. DXT Class II 1987-09-14
K871492 AIS ANGIOSCOPE Advanced Interventional Systems, Inc. DQX Class II 1987-09-14
K872378 WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR C.R. Bard, Inc. DTN Class II 1987-09-14
K872542 SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER Angiomedics, Inc. LIT Class II 1987-09-14
K870850 MOD 482 Hoffrel Instruments, Inc. JOP Class II 1987-09-08
K863387 MULTIPLE Del Mar Avionics DXK Class II 1987-09-04
K871389 HOLTER ST SYSTEM, MODEL NO. 5000-20 Holter Data Services DSI Class II 1987-09-01
K872167 CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 American Bentley DTP Class II 1987-09-01
K870804 CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 American Bentley DTR Class II 1987-09-01
K871129 CAVROPUMP Life-Tech Intl., Inc. DXT Class II 1987-08-28
K872107 WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR Minntech Corp. DTZ Class II 1987-08-28
K871110 CORONARY ARTERY BYPASS GRAFT (CABG) MARKER Edward Weck, Inc. DSY Class II 1987-08-27
K872074 5 MHZ TRANSDUCER Sonicaid, Inc. JOP Class II 1987-08-25

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