meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
1995-10-12

Clearances · page 119 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K951858 TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS Medtronic Vascular DTB Class III 1995-10-12
K950854 VITALOGRAPH 2110 SOFTWARE INTERFACE Vitalograph , Ltd. DSH Class II 1995-10-12
K953287 DIASTAT VASCULAR ACCESS GRAFT W. L. Gore & Associates, Inc. DYF Class II 1995-10-06
K951370 ZYMED TELEMETRY SYSTEM; MODEL T8010 Zymed Medical Instrumentation DSI Class II 1995-10-06
K953288 DIASTAT VASCULAR ACCESS GRAFT W. L. Gore & Associates, Inc. DSY Class II 1995-10-06
K951684 AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM) Digital Air Corp. JOW Class II 1995-10-06
K952532 AFFINITY ARTERIAL BLOOD FILTER Avecor Cardiovascular, Inc. DTM Class II 1995-10-06
K950398 CATHETER, BALLOON TYPE Interventional Therapeutics Corp. DQO Class II 1995-10-05
K951603 CARDIMA, INC. FORERUNNER Cardima, Inc. DQY Class II 1995-10-05
K951371 1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION Siemens Medical Solutions USA, Inc. DSI Class II 1995-10-04
K950821 HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24 Hewlett-Packard Co. DSI Class II 1995-10-03
K952328 NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 Biotronik, Inc. DXY Class III 1995-09-29
K953417 MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS Cook Pacemaker Corp. DXY Class III 1995-09-29
K953952 DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF Deroyal Industries, Inc. DXQ Class II 1995-09-28
K945511 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR Physio-Control Corp. MPE Class II 1995-09-26
K952885 SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER Spacelabs Medical, Inc. DSI Class II 1995-09-26
K951159 FASGUIDE Target Therapeutics DQY Class II 1995-09-25
K935668 MEDRAD SPECTRIS MR INJECTOR Medrad, Inc. DXT Class II 1995-09-25
K953023 PRECEDER GUIDEWIRE Boston Scientific Corp DQX Class II 1995-09-21
K953126 OXILINK (SMALL, MEDIUM, LARGE) Bci Intl., Inc. DQA Class II 1995-09-21
K941252 RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR Ansar DRT Class II 1995-09-20
K953515 SCIMED TRIGUIDE GUIDE CATHETERS Scimed Life Systems, Inc. DQY Class II 1995-09-19
K952651 LIFE SOUND SENSOR Flowscan, Inc. DQC Class I 1995-09-19
K952846 EPICARDIA Medicomp, Inc. DQK Class II 1995-09-18
K953218 AUSCULATOR GPS Lyte Industries, Inc. DQD Class II 1995-09-18
K952825 CUFF GUARD Bowen Medical Services, Inc. DXQ Class II 1995-09-15
K950440 DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD J-Lloyd Medical, Inc. DQO Class II 1995-09-15
K951110 CARDIO SERV Hellige GmbH LDD Class II 1995-09-15
K953466 GENERICUFF Generic Medical, Inc. DXQ Class II 1995-09-15
K950607 UST-5268P-5 TRANSDUCER Aloka Co., Ltd. KRK Class II 1995-09-15
K950479 DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MM Nikomed U.S.A., Inc. DRX Class II 1995-09-13
K952864 BAIR HUGGER MODEL 655 BLANKET Augustine Medical, Inc. DWJ Class II 1995-09-12
K953114 EVOLUTION MICROCATHETER Boston Scientific Corp DQO Class II 1995-09-12
K944362 HEARTCARD CARDIAC EVENT MONITOR Instromedix, Inc. DXH Class II 1995-09-07
K952101 MARQUETTE DEFIB ELECTRODES Marquette Electronics, Inc. MKJ Class III 1995-09-07
K952086 TROPICAIR CONVECTIVE WARMING BLANKETS Seabrook Medical Systems, Inc. DWJ Class II 1995-09-06
K946196 TROPICAIR CONVECTIVE WARING SYSTEM Seabrook Medical Systems, Inc. DWJ Class II 1995-09-06
K950476 DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM Nikomed U.S.A., Inc. DRX Class II 1995-09-06
K952364 OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) Ela Medical, Inc. DXY Class III 1995-09-01
K951950 PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING Pacesetter, Inc. DTB Class III 1995-08-31
K952566 OSCILFLATOR Surgical Technologies, Inc. MAV Class II 1995-08-31
K952206 PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING Pacesetter, Inc. DTB Class III 1995-08-31
K952562 CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE Cardio Metrics, Inc. DQX Class II 1995-08-29
K950416 BAIR HUGGER MODEL 600 UNIT, BLANKETS Augustine Medical, Inc. DWJ Class II 1995-08-29
K952327 SMARTSAT PULSE OXIMETRY ANALYZER Clinical Dynamics Corp. DQA Class II 1995-08-25
K952531 QUEST VEIN GRAFT PERFUSION SET Quest Medical, Inc. DTL Class II 1995-08-24
K953425 POLYETHYLENE TEREPHTHALATE (PET) PLEDGET Davis & Geck, Inc. DXZ Class II 1995-08-21
K953289 TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET Davis & Geck, Inc. DXZ Class II 1995-08-21
K952874 TRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. KRA Class II 1995-08-21
K952270 DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN Sorin Biomedical, Inc. DTM Class II 1995-08-21
K952828 MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM Boston Scientific Corp DYB Class II 1995-08-18
K952430 FINESSE GUIDEWIRE CORONARY Flexmedics DQX Class II 1995-08-18
K951413 FOGARTY-HYDRAGRIP SURGICAL CLAMPS Baxter Healthcare Corp DXC Class II 1995-08-18
K950882 BRAUN SELECTIVE ANGIOGRAPHIC CATHETER B.Braun Medical, Inc. DQO Class II 1995-08-17
K952345 MEDI-TECH PLATFORM GUIDE CATHETER Medi-Tech, Inc. DQY Class II 1995-08-17
K945693 CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER Cardiovascular Dynamics, Inc. LIT Class II 1995-08-17
K952316 NELLCOR SYMPHONY N-3000 PULSE OXIMETER Nellcor, Inc. DQA Class II 1995-08-17
K950020 HOLTER PACERCORDER(R) Del Mar Avionics DSH Class II 1995-08-17
K952222 NELLCOR N-20PA PORTABLE PULSE OXIMETER Nellcor, Inc. DQA Class II 1995-08-15
K945429 SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) Spacelabs Medical, Inc. DSI Class II 1995-08-15
K943861 CAPIOX SP PUMP HEAD Terumo Corp. KFM Class II 1995-08-15
K950389 SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR Sorba Medical Systems, Inc. DSB Class II 1995-08-15
K952173 HEWLETT-PACKARD MODEL M1264B CATHSTATION Hewlett-Packard Co. DPS Class II 1995-08-11
K952221 BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 Boston Scientific Corp DSP Class II 1995-08-11
K940092 USCI INPUT INTRODUCER SET Usci, Div. C.R. Bard, Inc. DYB Class II 1995-08-10
K945229 ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS Arrow Intl., Inc. DRF Class II 1995-08-08
K950910 TRANSIT-2 INFUSION CATHETER Cordis Neurovascular, Inc. DQO Class II 1995-08-08
K952205 ACS POWERBASE GUILDING CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1995-08-04
K950155 RAPID-TRAK(TM) INTRODUCER SHEATH Cardio Vascular Concepts, Inc. DYB Class II 1995-08-02
K952185 CORDIS BRITE TIP, ENVOY GUIDING CATHETER Cordis Corp. DQY Class II 1995-08-02
K952872 SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER Scimed Life Systems, Inc. KRA Class II 1995-07-27
K951447 DYNABITE CARDIOVASCULAR BIOPSY FORCEPS Portlyn Corp. DWZ Class II 1995-07-27
K934785 MULTIPACE Electro-Catheter Corp. LDF Class II 1995-07-27
K950179 MEDTRONIC(R) GC III CORONARY GUIDING CATHETER Medtronics Interventional Vascular DQY Class II 1995-07-25
K950813 MOLLRING CUTTER Cardio Vascular Concepts, Inc. DWX Class II 1995-07-25
K943917 CAPIOX ARTERIAL FILTER Terumo Medical Corp. DTM Class II 1995-07-25
K951802 SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT Scimed Life Systems, Inc. DXT Class II 1995-07-21
K952067 CORDIS STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1995-07-20
K944259 FEMOSTOP II Radi Medical Systems AB DXC Class II 1995-07-20
K946333 IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER Irvine Biomedical, Inc. DRF Class II 1995-07-18
K945754 NEWOX2 Bci Intl., Inc. DQA Class II 1995-07-17
K925078 SPECTRADOP Bennett and Assoc., Inc. JOP Class II 1995-07-17
K944966 UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 Medtronic Blood Systems, Inc. LDF Class II 1995-07-14
K944956 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 The Heart Valve Div. Medtronic Cardiovascular Surg LDF Class II 1995-07-14
K944957 TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 Medtronic Blood Systems, Inc. LDF Class II 1995-07-14
K942543 ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS Sankei Co., Ltd. DXN Class II 1995-07-14
K951605 SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM Spacelabs, Inc. DSH Class II 1995-07-14
K945099 PARAMETERS MONITORES Ivy Biomedical Systems, Inc. MHX Class II 1995-07-13
K940039 PELLETHANE 75D Medtronic Vascular DXY Class III 1995-07-12
K945934 URESIL(R) GUIDEWIRE Uresil Corp. DQX Class II 1995-07-10
K944260 ECG ELECTRODE Msb , Ltd. DRX Class II 1995-07-07
K950485 GRAPHIC CONTROLS PROTRACE ECG ELECTRODE Graphic Controls Corp. DRX Class II 1995-07-07
K945479 MEDI-TRACE(R) 500 ECG ELECTRODE Graphic Controls Corp. DRX Class II 1995-07-07
K950488 GRAPHIC CONTROLS BIOTAC ECO ELECTRODE Graphic Controls Corp. DRX Class II 1995-07-03
K950489 GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE Graphic Controls Corp. DRX Class II 1995-07-03
K945985 PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 Burdick, Inc. DQK Class II 1995-07-03
K944219 SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS Gish Biomedical, Inc. DTR Class II 1995-06-30
K951087 TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD Pacesetter, Inc. DTB Class III 1995-06-29
K951486 MODEL PV2000 VASCULAR MICROLABORATORY Vasamedics, LLC DPW Class II 1995-06-29
K942196 3050 DIASCOPE NT PATIENT MONITOR S & W Medico Teknik A/S DSI Class II 1995-06-28

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