meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
52
Latest Decision
2007-11-21

Clearances · page 73 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K073013 CTU676 DEVICE Compression Technologies Unlimited, Inc. JOW Class II 2007-11-21
K071521 TERUMO HX2 TEMPERATURE MANAGEMENT SYSTEM Terumo Cardiovascular Systems Corp. DWC Class II 2007-11-21
K072556 HEMOSTASIS VALVE Merit Medical Systems, Inc. DTL Class II 2007-11-20
K073035 PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS Merit Medical Systems, Inc. DRE Class II 2007-11-20
K072202 CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) Biosense Webster, Inc. DQK Class II 2007-11-19
K072502 MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies DQK Class II 2007-11-19
K073104 SKINTACT AND VARIOUS OTHER TRADENAMES Leonhard Lang GmbH DRX Class II 2007-11-16
K072698 CONFIDANT 2.5 Confidant, Inc. DRG Class II 2007-11-16
K072593 A-PLUS ARTERIAL PULSE WAVEFORM ANALYSIS SYSTEM AND PC SOFTWARE Healthstats International Pte. , Ltd. DXN Class II 2007-11-15
K072769 ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS Possis Medical, Inc. QEZ Class II 2007-11-14
K072371 ODYSSEY WORKSTATION Stereotaxis, Inc. DXX Class II 2007-11-14
K072248 VIAPEEL PEELABLE INTRODUCER Enpath Medical, Inc. DYB Class II 2007-11-09
K072748 MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems, Inc. MCW Class II 2007-11-09
K071918 CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 Thermogear, Inc. DWJ Class II 2007-11-09
K071826 THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 Fox Hollow Technologies QEZ Class II 2007-11-09
K072724 CXI SUPPORT CATHETER Cook, Inc. KRA Class II 2007-11-09
K071802 TESLA GUARD, MODEL EFT G04 Mammendorfer Institut Fur Physik Und Medizin GmbH MWI Class II 2007-11-09
K072156 OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER Usci Ireland DQY Class II 2007-11-09
K073025 VASCUTRAK II PTA DILATATION CATHETER Thermopeutix, Inc. Dba Ymed, Inc. PNO Class II 2007-11-09
K072240 GUNTHER TULIP VENA CAVA FILTER Cook, Inc. DTK Class II 2007-11-08
K072430 ZOLL PEDIPADZ REDUCED ENERGY ELECTRODE ZOLL Medical Corporation MKJ Class III 2007-11-06
K070550 AUSCO ES-3100 Koratek Company, Ltd. DQD Class II 2007-11-06
K072666 BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM Bio Compression Systems, Inc. JOW Class II 2007-11-05
K071610 MEDIAID PULSE OXIMETER M30 AND M34 Mediaid, Inc. DQA Class II 2007-11-05
K072919 VENDYS, MODEL 6000 B B/C Endothelix, Inc. DQK Class II 2007-11-02
K071576 TEXTRONICS ECG ELECTRODE Textronics, Inc. DRX Class II 2007-11-02
K072313 AMPLATZER TORQVUE DELIVERY SYSTEM Aga Medical Corp. DQY Class II 2007-11-02
K071330 GALTSTICK INTRODUCER SYSTEM Galt Medical Corp. DRE Class II 2007-10-31
K072130 PTFE PEEL AWAY MICROINTRODUCER Intromed DYB Class II 2007-10-31
K072990 GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID Medtronic, Inc. NTE Class II 2007-10-31
K072091 D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR Sorin Group Italia S.R.L. DTZ Class II 2007-10-29
K072026 RNK ELECTRONIC STETHOSCOPE Rnk Products, Inc. DQD Class II 2007-10-26
K072200 STIMLAB Micropace Pty, Ltd. JOQ Class II 2007-10-26
K072800 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems, Inc. MCW Class II 2007-10-25
K070749 ESTECH PERCUTANEOUS INSERTION DILATOR KIT Coombs Medical Device Consulting DRE Class II 2007-10-24
K072655 ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR Genesee Biomedical, Inc. KRH Class II 2007-10-23
K070865 EXPANDING VASCULAR SHEATH Applied Medical DYB Class II 2007-10-23
K072824 FOX SV PTA CATHETER Abbott Laboratories LIT Class II 2007-10-23
K072705 ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J Asahi Intecc Co., Ltd. DQX Class II 2007-10-23
K072362 NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG Novalung GmbH DTZ Class II 2007-10-23
K072235 PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DQA Class II 2007-10-19
K072516 MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR Midmark Diagnostics Group MWI Class II 2007-10-18
K072735 PULSION PICCO-2, MODEL 8500 Pulsion Medical Systems AG DXG Class II 2007-10-18
K070212 CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM) Ovalum , Ltd. DQX Class II 2007-10-12
K072225 ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. PNO Class II 2007-10-12
K072295 CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE Oridion Capnography, Inc. DQA Class II 2007-10-11
K071384 MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 Nihon Seimitsu Sokki Co., Ltd. DXN Class II 2007-10-09
K072155 PIONEER CATHETER Medtronic, Inc. PDU Class II 2007-10-05
K072233 SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS Leonhard Lang GmbH MKJ Class III 2007-10-05
K072526 MICRUS COURIER ENZO MICROCATHETER 0.0190 Micrus Endovascular Corporation DQO Class II 2007-10-05
K072507 ENDOWAVE INFUSION SYSTEM Ekos Corp. QEY Class II 2007-10-04
K070502 RADIUS SNARE Radius Medical Technologies, Inc. DQY Class II 2007-10-04
K070798 ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS Coeur, Inc. DXT Class II 2007-10-04
K071085 E3-80 PORTABLE ECG RECORDER & ANALYZER Micro-Star International Co., Ltd. MWJ Class II 2007-10-03
K072051 NOVATOME, MODEL: SU101-50 Scholten Surgical Instruments, Inc. DWZ Class II 2007-10-03
K072008 BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER Braemar, Inc. DRG Class II 2007-10-03
K063035 SLEUTH IMPLANTABLE ECG MONITORING SYSTEM Transnoma Medical, Inc. MXC Class II 2007-10-01
K071727 QXT EXTRACTION CATHETER Vascular Solutions, Inc. QEZ Class II 2007-09-28
K071762 OMNIWAVE ENDOVASCULAR SYSTEM Omnisonics Medical Technologies QEY Class II 2007-09-27
K072431 ASAHI PTCA GUIDE WIRE, X-TREME Asahi Intecc Co., Ltd. DQX Class II 2007-09-26
K070156 BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 Cardiodynamics International Corp. DSB Class II 2007-09-26
K071457 MODIFICATION TO RADIUS SNARE Radius Medical Technologies, Inc. MMX Class II 2007-09-25
K071805 NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX Datascope Corp. DSI Class II 2007-09-25
K071744 AVIAFIT PULSATING LEGBAND Flowmedic , Ltd. JOW Class II 2007-09-25
K071472 PLANET 55 Larsen & Toubro Limited MWI Class II 2007-09-21
K071982 MODIFICATION TO: UNITY NETWORK ID Ge Medical Systems Information Technologies MWI Class II 2007-09-21
K072283 DORADO PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. DQY Class II 2007-09-19
K063735 PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112 Presym, Inc. DRT Class II 2007-09-19
K072364 PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES Pulsion Medical Systems AG KRB Class II 2007-09-19
K070979 PULL TAB SQUEEZE FLUSH Icu Medical, Inc. KRA Class II 2007-09-19
K070816 PERIPHERAL GUIDING SHEATH Micrus Design Technology, Inc. DYB Class II 2007-09-19
K072389 MODIFICATION TO HYPERQ SYSTEM Biological Signal Processing, Ltd. MWI Class II 2007-09-18
K072316 PRECIOUS PLUS GUIDE CATHETER Asahi Intecc Co., Ltd. DQY Class II 2007-09-17
K072278 BRK TRANSSEPTAL NEEDLE St Jude Medical DRC Class II 2007-09-13
K071672 SENTEC DIGITAL MONITORING SYSTEM Sentec AG DQA Class II 2007-09-12
K072297 BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM Cardiva Medical, Inc. DXC Class II 2007-09-12
K063658 INTRAVASCULAR INTRODUCER SYSTEM Applied Medical Resources Corp. DYB Class II 2007-09-12
K071321 POCKETCPR Bio-Detek, Inc. LIX Class II 2007-09-12
K072308 D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED Sorin Group Italia S.R.L. DTM Class II 2007-09-12
K063609 RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER Shl Telemedicine International , Ltd. DXH Class II 2007-09-12
K072269 ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 Possis Medical, Inc. QEZ Class II 2007-09-08
K072272 HONEYWELL HOMMED CENTRAL STATION 4.0 Honeywell Hommed, LLC DXN Class II 2007-09-07
K071391 PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 Philips Medical Systems, Inc. MSX Class II 2007-09-07
K071348 EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM Mennen Medical , Ltd. DQK Class II 2007-09-07
K071911 CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR Innovision A/S DQK Class II 2007-09-07
K071196 DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS Coeur, Inc. DQO Class II 2007-09-06
K072167 COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE Advanced Vascular Dynamics DXC Class II 2007-09-06
K071606 BIOSIGN CENTRAL STATION Obs Medical MWI Class II 2007-08-31
K072172 JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE Maquet Cardiopulmonary, AG DWF Class II 2007-08-31
K071225 INNOVASA STAT*SEAL TOPICAL HEMOSTAT Innovasa, Inc. DXC Class II 2007-08-31
K071660 VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900 Volcano Corporation OBJ Class II 2007-08-31
K070795 SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM Atcor Medical Pty, Ltd. DSK Class II 2007-08-31
K071168 THE PORTABLE ANSISCOPE Dyansys, Inc. DPS Class II 2007-08-31
K071564 MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 Philips Medical Systems DRG Class II 2007-08-31
K071427 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS Cardiovascular Systems, Inc. MCW Class II 2007-08-30
K072353 PORTABLE ECSCOPE Dyansys Corp DPS Class II 2007-08-30
K072217 ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M Nihon Kohden America, Inc. DPS Class II 2007-08-30
K071367 FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 LeMaitre Vascular, Inc. MJN Class II 2007-08-29
K070661 VITALCOR FEATHERWEIGHT VASCULAR CLAMPS Vitalcor, Inc. DXC Class II 2007-08-29
K071751 LIFESYNC ADAPTER, MODEL LS-302 Lifesync Corporation DSA Class II 2007-08-27

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