meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
2008-12-12

Clearances · page 69 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K083370 D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 Artegraft, Inc. QEW Class II 2008-12-12
K082559 SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER Spectranetics Corp. DQY Class II 2008-12-11
K082385 CHAPERON GUIDING CATHETER MicroVention, Inc. DQY Class II 2008-12-11
K082008 BIONET BM3PLUS PATIENT MONITOR Bionet Co., Ltd. MWI Class II 2008-12-11
K082561 SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS Spectranetics Corp. DQY Class II 2008-12-10
K081645 AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 St Jude Medical DYB Class II 2008-12-09
K080428 ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY Medtronic, Inc. DQY Class II 2008-12-09
K082308 MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR Edwards Lifesciences, LLC DXG Class II 2008-12-09
K081828 ZOLL R SERIES BLS DEFIBRILLATOR ZOLL Medical Corporation MKJ Class III 2008-12-09
K082922 FREEWAY AND RAILRUNNER GUIDEWIRES Lake Region Mfg., Inc. DQX Class II 2008-12-09
K082580 SPECTRA GUIDEWIRE INTRODUCER NEEDLE Spectra Medical Devices, Inc. DYB Class II 2008-12-08
K082670 MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET Medtronic, Inc. DQY Class II 2008-12-04
K082935 VISION WIRE CORONARY GUIDEWIRE Biotronik, Inc. DQX Class II 2008-12-04
K081697 THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 Access Scientific, Inc. DYB Class II 2008-12-04
K080903 ZOLL E SERIES WITH INTIBATION ASSIST OPTION ZOLL Medical Corporation MKJ Class III 2008-12-04
K083343 HEADWAY 17 MICROCATHETER MicroVention, Inc. DQY Class II 2008-12-04
K082854 NANOCORSS .014 OTW PTA DILATATION CATHETER Ev3, Inc. DQY Class II 2008-12-04
K082380 VICARDIO 12B Energy-Lab Technologies GmbH DPS Class II 2008-12-03
K082546 REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) Unimed Medical Supplies, Inc. DQA Class II 2008-12-02
K083078 QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 Quanta Computer, Inc. DXN Class II 2008-11-26
K083115 MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 Intel Corp. DRG Class II 2008-11-26
K083321 CARDIO-VIEW Curlview Igt, LLC DXJ Class II 2008-11-26
K082888 INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 Draeger Medical Systems, Inc. DQA Class II 2008-11-26
K083340 LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE Levitronix, LLC DWA Class II 2008-11-26
K082785 NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES Nihon Kohden America, Inc. MHX Class II 2008-11-26
K083139 VIPERSPHERE PTA BALLOON CATHETER Cardiovascular Systems, Inc. DQY Class II 2008-11-25
K082253 BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT Bodystat , Ltd. MNW Class II 2008-11-25
K082861 AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 Amco International Manufacturing & Design, Inc. MKJ Class III 2008-11-25
K082881 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 Microlife Intellectual Property GmbH DXN Class II 2008-11-24
K083228 PHILIPS INTELLIVUE MP5 PATIENT MONITOR Philips Medizin Systeme Boblingen GmbH MHX Class II 2008-11-24
K083125 NEURON SELECT CATHETER SIZE 070 Penumbra, Inc. DQY Class II 2008-11-21
K083146 ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000 Asahi Intecc Co., Ltd. DQX Class II 2008-11-21
K082579 EVERCROSS .035 OTW PTA DILATATION CATHETER Ev3, Inc. DQY Class II 2008-11-20
K082339 ENABLER-P SUPPORT CATHETER Endocross, Ltd. DQY Class II 2008-11-20
K082851 MULTLINK CABLE AND LEADWIRE SYSTEM Ge Medical Systems Information Technologies DSA Class II 2008-11-19
K082348 FIBERNET EMBOLIC PROTECTION SYSTEM Lumen Biomedical, Inc. NTE Class II 2008-11-18
K081940 AVALON ELITE VASCULAR ACCESS KIT Avalon Laboratories, LLC DRE Class II 2008-11-18
K081986 SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE Oscor, Inc. DRC Class II 2008-11-14
K082734 A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR A&D Engineering, Inc. DXN Class II 2008-11-13
K082412 VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 Mapquet Cardiopulmonary AG DTP Class II 2008-11-10
K082013 CLUE MEDICAL AND CLUE MEDICAL BASIC Telovital GmbH Telemedizin DPS Class II 2008-11-10
K082641 FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL Contec Medical System Co., Ltd. DQA Class II 2008-11-10
K083148 TELECTRODE WET GEL ECG ELECTRODE Bio Protech, Inc. DRX Class II 2008-11-07
K082475 REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 Medtronic, Inc. DSI Class II 2008-11-07
K083083 AGILIS NXT STEERABLE INTRODUCER St Jude Medical DYB Class II 2008-11-06
K082933 PASSEO-35 PTA CATHETER Biotronik, Inc. DQY Class II 2008-11-03
K082646 OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER Usci Ireland DQY Class II 2008-11-03
K082981 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT Cardiovascular Systems, Inc. MCW Class II 2008-10-31
K082305 G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS C.R. Bard, Inc. DTK Class II 2008-10-31
K083135 MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 Thermogear, Inc. DWJ Class II 2008-10-31
K072752 BP LIMBO XL, BPTANGO XL, BP SALSA XL Datadancer Medical Systems DQK Class II 2008-10-31
K082290 NEURON DELIVERY CATHETER 070 Penumbra, Inc. DQY Class II 2008-10-31
K082847 PINNACLE ROII INTRODUCER SHEATH Terumo Medical Corp. DYB Class II 2008-10-29
K082163 FLOWMEDICA BENEPHIT INFUSION SYSTEMS Flowmedica, Inc. KRA Class II 2008-10-29
K083021 APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR Sorin Group Italia S.R.L. DTZ Class II 2008-10-29
K082357 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). Microlife Intellectual Property GmbH DXN Class II 2008-10-29
K082870 VTI INTRAOPERATIVE DOPPLER SYSTEMS Vascular Technology Incorporated DPW Class II 2008-10-28
K083043 KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201 Shenzhen Kingyield Technology Co., Ltd. DXN Class II 2008-10-27
K082868 MULLINS-X, MODEL 250X NuMED, Inc. DQY Class II 2008-10-24
K081587 KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 Krell Precision (Yang Zhou) Co., Ltd. MNW Class II 2008-10-24
K082139 EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 Edwards Lifesciences, LLC DXZ Class II 2008-10-23
K082812 OMRON MODEL HBP-2070 VITAL SIGNS MONITOR Omron Healthcare, Inc. MWI Class II 2008-10-22
K082564 HYPERQ SYSTEM Biological Signal Processing, Ltd. MWI Class II 2008-10-20
K080854 DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100 Suntech Medical, Inc. DXQ Class II 2008-10-20
K082599 NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT Cnsystem Medizintechnik AG DXN Class II 2008-10-17
K082199 SPIRALFUSE PERIPHERAL INFUSION SYSTEM Bacchus Vascular, Inc. QEY Class II 2008-10-17
K081438 MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT Lifenet Health DXZ Class II 2008-10-17
K080908 INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM Innercool Therapies, Inc.- A Delaware Corporation NCX Class II 2008-10-17
K073582 VRIICU SYSTEM Deep Breeze , Ltd. OCR Class II 2008-10-15
K081626 FLOWPICC CONSOLE Vasonova, Inc. OBJ Class II 2008-10-15
K082063 PRELUDE SHORT SHEATH INTRODUCER Merit Medical Systems, Inc. DYB Class II 2008-10-15
K081793 PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER Philips Medizin Systeme Boeblingen GmbH MHX Class II 2008-10-14
K081654 HEM-9000AI Omron Healthcare, Inc. DXN Class II 2008-10-10
K082718 TEMPUSIC PATIENT MONITOR Remote Diagnostic Technologies , Ltd. DXH Class II 2008-10-10
K082052 MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK Masimo Corporation DQA Class II 2008-10-10
K082959 PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS Unimed Medical Supplies, Inc. DSA Class II 2008-10-10
K080348 OXISCAN II DATA MANAGEMENT SYSTEM Airsep Corp. DQA Class II 2008-10-09
K081187 BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 Bridgepoint Medical DQX Class II 2008-10-08
K082242 ICON, MODEL C3 Osypka Medical, Inc. DSB Class II 2008-10-08
K082280 SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR Philips Medical Systems North America Co. MHX Class II 2008-10-08
K081820 AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR Avalon Laboratories, LLC DWF Class II 2008-10-06
K082664 JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 Pathway Medical Technologies, Inc. MCW Class II 2008-10-06
K082149 LYMPHA PRESS OPTIMAL, MODEL# 1201AP Mego Afek AC , Ltd. JOW Class II 2008-10-06
K082544 QUART ARTERIAL FILTER WITH BIOLINE COATING Maquet Cardiopulmonary, AG DTM Class II 2008-10-03
K081933 AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR Avalon Laboratories, LLC DWF Class II 2008-10-03
K081799 GORE TRI-LOBE BALLOON CATHETER W. L. Gore & Associates, Inc. DQY Class II 2008-10-03
K080825 IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 Impedimed Pty , Ltd. OBH Class II 2008-10-03
K082633 INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN DSI Class II 2008-10-03
K080901 LBI EMBOLECTOMY SYSTEM Lumen Biomedical, Inc. QEW Class II 2008-10-02
K073700 6F PROXIS SYSTEM St. Jude Medical, Inc. DQY Class II 2008-10-02
K081572 SMARTSIGNS MINPULSE Huntleigh Healthcare , Ltd. DQA Class II 2008-10-01
K081989 MODIFICATION TO FETCH ASPIRATION CATHETER Possis Medical, Inc. QEZ Class II 2008-09-26
K082256 LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE Integrated Medical Systems, Inc. MWI Class II 2008-09-26
K082366 LIFEBED PATIENT VIGILANCE SYSTEM Hoana Medical, Inc. DRT Class II 2008-09-26
K080700 DUOFLO CATHETER Thermopeutix, Inc. MJN Class II 2008-09-26
K081625 FLOWPICC STYLET Vasonova, Inc. OBJ Class II 2008-09-26
K082519 FINECROSS MG CORONARY MICRO-GUIDE CATHETER Terumo Medical Corp. KRA Class II 2008-09-26
K082685 GALAXY 55 Larsen & Toubro Limited MWI Class II 2008-09-26
K080933 HANDHELD ECG MONITOR, MODEL MD100 Beijing Choice Electronic Technololgy Co., Ltd. DPS Class II 2008-09-26
K082524 MINI GHOST, MODEL: 507 NuMED, Inc. DQY Class II 2008-09-26

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