meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
49
Latest Decision
2009-05-22

Clearances · page 67 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K090665 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 Abbott Vascular-Vascular Solutions NTE Class II 2009-05-22
K090037 MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG Medicalgorithmics SP Z.O.O. DSI Class II 2009-05-22
K083833 ENABLER-P CATHETER, 1000 PART NUMBER:1160 Endocross, Ltd. DQY Class II 2009-05-22
K083328 ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 St Jude Medical DQK Class II 2009-05-22
K091206 SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL Transoma Medical MXC Class II 2009-05-18
K082403 MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT Gish Biomedical, Inc. DTZ Class II 2009-05-15
K091119 MODIFICATION TO THE CROSSER SYSTEM Flowcardia, Inc. PDU Class II 2009-05-15
K090834 EPICARDIA 5000 Medicomp, Inc. DSI Class II 2009-05-15
K083821 VITAL SIGNS MONITOR Edan Instruments, Inc. DQA Class II 2009-05-14
K081130 BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER Bridgepoint Medical DQY Class II 2009-05-14
K081803 ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM St Jude Medical DRF Class II 2009-05-13
K083214 AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 Aga Medical Corp. DQY Class II 2009-05-12
K083838 SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES Fook Tin Technologies Limited MNW Class II 2009-05-12
K090363 ZIO PATCH, MODEL Z100 iRhythm Technologies, Inc. DSH Class II 2009-05-08
K091068 ACCUTORR V MONITOR, MODEL 0998-00-2000 Datascope Corp., Patient Monitoring Division DXN Class II 2009-05-08
K081138 SAFEFLO VENA CAVA FILTER Rmt Medical Technilogies, Inc. DTK Class II 2009-05-07
K082134 CIRCULATOR BOOT Circulator Boot Corp. DRN Class II 2009-05-07
K090365 HANSEN MEDICAL ARTISAN S CONTROL CATHETER Hansen Medical, Inc. DXX Class II 2009-05-07
K090428 ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC Genesee Biomedical, Inc. KRH Class II 2009-05-07
K090335 HD GUIDE CATHETER Concentric Medical, Inc. DQY Class II 2009-05-06
K083922 MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 Micrus Endovascular Corporation DQO Class II 2009-05-06
K090913 CROSS-PILOT TURBO ELITE SUPPORT CATHETER Spectranetics Corp. DQY Class II 2009-05-04
K090360 PHILIPS M3001A MULTI MEASUREMENT SERVER Philips Medizin Systeme Boblingen GmbH DQA Class II 2009-05-04
K090870 ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY Micro Therapeutics, Inc. KRA Class II 2009-05-01
K090849 MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 Ev3, Inc. DQY Class II 2009-05-01
K090308 RESTEP DVY SYSTEM, MODEL RSP-101 Stortford Medical, LLC JOW Class II 2009-05-01
K083557 BCI WW1030 PULSE OXIMETER Smiths Medical Pm, Inc. DQA Class II 2009-05-01
K090963 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 Andon Health Co, Ltd. DXN Class II 2009-04-30
K090556 SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE Spacelabs Healthcare Medical Equipment (Suzhou) CO MHX Class II 2009-04-30
K090205 BCI WW1021 PC APPLICATION Smiths Medical Pm, Inc. DQA Class II 2009-04-28
K090822 ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER Cook, Inc. DQY Class II 2009-04-27
K083793 STEERABLE GUIDE CATHETER Evalve, Inc. DRA Class II 2009-04-27
K083351 PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P Comdek Industrial Corp. DQA Class II 2009-04-24
K083630 CLUE MEDICAL AND CLUE MEDICAL BASIC Telovital GmbH Telemedizin DXH Class II 2009-04-23
K091137 ULTIMUM/ENGAGE/ENGAGE TR St Jude Medical DYB Class II 2009-04-22
K090058 YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB Ya Horng Electronic Co., Ltd. DXN Class II 2009-04-22
K090074 HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS Hygia Health Services, Inc. JOW Class II 2009-04-22
K090147 BLOOD MONITORING UNIT, MODEL BMU 40 Maquet Cardiopulmonary, AG DRY Class II 2009-04-22
K083794 MECC SET WITH BIOLINE COATING Maquet Cardiopulmonary, AG KFM Class II 2009-04-21
K090022 PARADIS VASO SHIELD Spinemedica, LLC OMR Class II 2009-04-20
K083834 TERUMO PALL AL6X ARTERIAL FILTER Terumo Cardiovascular Systems Corp. DTM Class II 2009-04-17
K090728 HYPERGLIDE OCCLUSION BALLOON SYSTEM Ev3, Inc. MJN Class II 2009-04-16
K083111 IMPELLA 5.0 CATHETER FAMILY Abiomed, Inc. KFM Class II 2009-04-16
K083623 CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 Edwards Lifesciences, LLC KRH Class II 2009-04-15
K090886 RTX 3371 Tunstall Healthcare DRG Class II 2009-04-15
K090702 MODIFICATION TO DASH 2500 PATIENT MONITOR Ge Medical Systems Information Technologies MHX Class II 2009-04-15
K090999 BIOCARDIA MORPH SHEATH GUIDE Biocardia, Inc. DYB Class II 2009-04-15
K083787 BCI WW1000 PULSE OXIMETER, MODEL WW1000 Smiths Medical Pm, Inc. DQA Class II 2009-04-15
K083534 LIFEBED NETWORK PATIENT VIGILANCE SYSTEM Hoana Medical, Inc. DRT Class II 2009-04-13
K083191 DETLOGIX ANNULOPLASTY RING, MODEL: 5100 Edwards Lifesciences, LLC KRH Class II 2009-04-10
K090014 CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE Caremate Medical Device Co., Ltd. DXQ Class II 2009-04-09
K083705 BCI WW1020 PULSE OXIMETER, MODEL WW1020 Smiths Medical Pm, Inc. DQA Class II 2009-04-09
K090801 ELECTRONIC HOUSE CALL Express MD Solutions, LLC DRG Class II 2009-04-08
K090253 ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 Possis Medical, Inc. QEZ Class II 2009-04-08
K090878 MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) Terumo Cardiovascular Systems Corp. DWF Class II 2009-04-03
K082327 INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C Somanetics Corp. MUD Class II 2009-04-03
K082846 APK SPO2 PULSE OXIMETER SENSOR APK Technology Co., Ltd. DQA Class II 2009-04-03
K090249 MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM Harbinger Medical, Inc. DPS Class II 2009-04-03
K090140 GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER William Cook Europe Aps DTK Class II 2009-04-03
K083466 MD2000A VITAL SIGN MONITOR, MODEL MD2000A Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2009-04-03
K090624 COOK MREYE EMBOLIZATION COILS Cook, Inc. KRD Class II 2009-04-02
K082782 REPLICATION MEDICAL VESSEL GUARD Replication Medical, Inc. OMR Class II 2009-04-02
K083622 LNCS OXIMETRY SENSORS Masimo Corporation DQA Class II 2009-04-02
K083674 PK-141 PATIENT CABLE Biotronik, Inc. DTC Class II 2009-04-01
K090323 REPROCESSED ELECTROPHYSIOLOGY CATHETERS Ascent Healthcare Solutions NLH Class II 2009-04-01
K090163 STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078 St Jude Medical DRB Class II 2009-04-01
K083820 VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C Vasomedical, Inc. DSH Class II 2009-04-01
K083784 PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, Vascular Solutions, Inc. QEZ Class II 2009-03-30
K090372 THE WAND MICROACCESS SAFETY INTRODUCER Access Scientific, Inc. DYB Class II 2009-03-30
K083169 EPTFE SLFTM SPIRAL VASCULAR GRAFT Tayside Flow Technologies Limited DSY Class II 2009-03-30
K083662 CRITICOOL Mtre Advanced Technology , Ltd. DWJ Class II 2009-03-26
K090659 ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY Medtronic, Inc. DQY Class II 2009-03-26
K082967 MORTARA STRESS ECHO BED Medical Positioning, Inc. DPS Class II 2009-03-26
K081775 THE MEDCOMP .010 VASCULAR GUIDEWIRES Medcomp DQX Class II 2009-03-25
K090120 REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106 Biosense Webster, Inc. DRF Class II 2009-03-24
K090286 PRESSUREMATE MANUAL FEMORAL ACCESS COMPRESSION DEVICE Advanced Vascular Dynamics DXC Class II 2009-03-23
K082439 DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT Shandong Weigao Medical Polymer Co., Ltd. DXT Class II 2009-03-23
K090664 DEVON ACCUBP CUFF Devon Medical, Inc. DXQ Class II 2009-03-23
K083750 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM Ge Medical Systems Information Technologies MHX Class II 2009-03-23
K090509 FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER Abbott Vascular-Vascular Solutions DQY Class II 2009-03-20
K090521 DIAMONDBACK 360 DBX Cardiovascular Systems, Inc. MCW Class II 2009-03-20
K090483 SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS Philips Medical Systems DPS Class II 2009-03-20
K082147 BODYMETRIX BX2000 Intelametrix, Inc. OMV Class II 2009-03-20
K083892 FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) Cas Medical Systems, Inc. DQA Class II 2009-03-19
K083697 FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M Fukuda Denshi USA, Inc. MHX Class II 2009-03-19
K083919 AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L. DQY Class II 2009-03-13
K090610 HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM Hospira, Inc. DRG Class II 2009-03-13
K082937 LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc. MKJ Class III 2009-03-11
K090325 JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) Pathway Medical Technologies, Inc. MCW Class II 2009-03-11
K083738 HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 Abbott Vascular DQX Class II 2009-03-11
K083677 PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 Commwell , Ltd. DRX Class II 2009-03-10
K083325 N-600X WITH SPD, OXIMAX N-600X Covidien DQA Class II 2009-03-09
K081081 ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2009-03-09
K082528 SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM Noble Anesthesia-Air, Inc. DQD Class II 2009-03-06
K083079 QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 Quanta Computer, Inc. DQA Class II 2009-03-05
K082487 M-50 SERIES SPO2 SENSOR Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2009-03-04
K090274 MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE Micrus Endovascular Corporation DQX Class II 2009-03-03
K083596 REEKROSS FAMILY OR OTW PTA CATHETERS ClearStream Technologies , Ltd. DQY Class II 2009-03-02
K082771 PROTRON TECHNOLOGIES, LLC STETHOTRON Protron Technologies, LLC DQD Class II 2009-02-27
K090046 CONCERTO DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. KRD Class II 2009-02-27

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