Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 47
- Latest Decision
- 2007-08-24
Clearances · page 74 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K071336 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 | Possis Medical, Inc. | QEZ | Class II | 2007-08-24 |
| K071029 | CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS) | Stereotaxis, Inc. | DQX | Class II | 2007-08-24 |
| K072195 | THROMCAT THROMBECTOMY CATHETER SYSTEM | Kensey Nash Corp. | MCW | Class II | 2007-08-23 |
| K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | Alsius Corp. | NCX | Class II | 2007-08-23 |
| K072012 | REFLEXION SPIRAL VARIABLE RADIUS CATHETER | St Jude Medical | DRF | Class II | 2007-08-22 |
| K071172 | MODIFIED MERCI RETRIEVER, MODEL 90060 | Concentric Medical, Inc. | NRY | Class II | 2007-08-22 |
| K071350 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | MCW | Class II | 2007-08-22 |
| K072131 | M3 MONITOR | Spectrum Medical , Ltd. | DRY | Class II | 2007-08-17 |
| K070036 | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES | Ascent Healthcare Solutions | NQG | Class I | 2007-08-17 |
| K072060 | QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V | Nihon Kohden America, Inc. | DPS | Class II | 2007-08-17 |
| K070034 | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES | Ascent Healthcare Solutions | NQG | Class I | 2007-08-17 |
| K070970 | NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F | Penumbra, Inc. | DQY | Class II | 2007-08-17 |
| K060980 | VENDYS MODEL 5000 B/BC | Endothelix, Inc. | DQK | Class II | 2007-08-16 |
| K070828 | KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | DXN | Class II | 2007-08-15 |
| K070826 | KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | DXN | Class II | 2007-08-15 |
| K071699 | AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 | Aga Medical Corp. | KRD | Class II | 2007-08-15 |
| K071923 | PTFE FLIXENE GRADUATED WALL GRAFT | Atrium Medical Corp. | DSY | Class II | 2007-08-14 |
| K070371 | FINGERTIP PULSE OXIMETER MD300C | Beijing Choice Electronic Technololgy Co., Ltd. | DQA | Class II | 2007-08-13 |
| K062974 | TESLA NIBP | Mammendorfer Institut Fur Physik Und Medizin GmbH | DXN | Class II | 2007-08-13 |
| K071529 | XTRACT CATHETER SYSTEM | Lumen Biomedical, Inc. | QEZ | Class II | 2007-08-10 |
| K071933 | ENDOWAVE INFUSION SYSTEM | Ekos Corp. | QEY | Class II | 2007-08-10 |
| K071327 | MEMO 3D SEMIRIGID ANNULOPLASTY RING | Sorin Biomedica Cardio S.R.L. | KRH | Class II | 2007-08-10 |
| K072070 | PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | MHX | Class II | 2007-08-10 |
| K071884 | BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 | Jawon Medical Co., Ltd. | MNW | Class II | 2007-08-09 |
| K071953 | RTX3370 | Rtx Healthcare A/S | DRG | Class II | 2007-08-08 |
| K071415 | DIGITAL PULSE OXIMETER, MODEL 7500FO | Nonin Medical, Inc. | DQA | Class II | 2007-08-08 |
| K070209 | FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR | Fego Precision Industrial Co;, Ltd. | DXN | Class II | 2007-08-08 |
| K063620 | EKOS MICRO-INFUSION SYSTEM | Ekos Corp. | QEY | Class II | 2007-08-06 |
| K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS | Peters Surgical | KRH | Class II | 2007-08-03 |
| K071960 | MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 | Meditech Kft. | DXN | Class II | 2007-08-03 |
| K071341 | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 | Medivance, Inc. | DWJ | Class II | 2007-08-03 |
| K070999 | BC (BODY COMPOSITION SOFTWARE) | Rjl Systems, Inc. | MNW | Class II | 2007-08-02 |
| K071214 | ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING | Genesee Biomedical, Inc. | KRH | Class II | 2007-07-31 |
| K071514 | ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 | Possis Medical, Inc. | QEZ | Class II | 2007-07-31 |
| K071342 | ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 | Possis Medical, Inc. | QEZ | Class II | 2007-07-31 |
| K071733 | DL900 SERIES HOLTER RECORDER | Braemar, Inc. | MWJ | Class II | 2007-07-24 |
| K071572 | CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER | Terumo Corp. | DTZ | Class II | 2007-07-23 |
| K061495 | VR LUNG ELECTROSONOGRAPH | Deep Breeze , Ltd. | OCR | Class II | 2007-07-18 |
| K071665 | SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 | Biotronik, Inc. | DQY | Class II | 2007-07-18 |
| K071494 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER | Terumo Corp. | DTZ | Class II | 2007-07-16 |
| K070500 | BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM | Ni Medical | DSB | Class II | 2007-07-16 |
| K063641 | PC-60, NON-INVASIVEPULSE OXIMETER | Shenzhen Creative Industry Co., Ltd. | DQA | Class II | 2007-07-13 |
| K071721 | ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371 | Asahi Intecc Co., Ltd. | DQX | Class II | 2007-07-13 |
| K070112 | RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM | Medcool, Inc. | DWJ | Class II | 2007-07-13 |
| K071664 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM | Bacchus Vascular, Inc. | QEY | Class II | 2007-07-13 |
| K071309 | BLUE MAX BALLOON DILATATION CATHETER | Boston Scientific Corp | LIT | Class II | 2007-07-13 |
| K071285 | DIGITAL PULSE OXIMETER, MODEL 7500 | Nonin Medical, Inc. | DQA | Class II | 2007-07-12 |
| K071725 | M2 MONITOR | Spectrum Medical , Ltd. | DRY | Class II | 2007-07-11 |
| K071227 | CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 | Spectranetics Corp. | PDU | Class II | 2007-07-11 |
| K062331 | HIGHPAK-12 | Ad Elektronik GmbH | MPD | Class II | 2007-07-10 |
| K070732 | BCI AUTOCON 3304 DIGITAL PULSE OXIMETER | Smiths Medical Pm, Inc. | DQA | Class II | 2007-07-09 |
| K071318 | MODIFICATION TO: STOCKERT S5 SYSTEM | Sorin Group Deutschland GmbH | DTQ | Class II | 2007-07-06 |
| K071574 | STIFFER COAXIAL MICRO-INTRODUCER KIT | Enpath Medical, Inc. | DYB | Class II | 2007-07-05 |
| K071253 | AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 | Medtronic Vascular | DTM | Class II | 2007-07-03 |
| K070743 | Z6 STIMULATOR | St Cardio Technologies, LLC | JOQ | Class II | 2007-07-02 |
| K071645 | MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S | Omron Healthcare, Inc. | MWI | Class II | 2007-07-02 |
| K061123 | PALM ECG RECORDER, MODEL EP-201/202 | Parama-Tech Company., Ltd. | DPS | Class II | 2007-06-29 |
| K071234 | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F | Siemens Medical Solutions USA, Inc. | OBJ | Class II | 2007-06-29 |
| K071024 | MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS | Masimo Corporation | DQA | Class II | 2007-06-29 |
| K070770 | GORE BALLOON SHEATH | W. L. Gore & Associates, Inc. | MJN | Class II | 2007-06-29 |
| K063339 | MEDICK MHM200 PERSONAL HEART MONITOR | Medick Healthcare , Ltd. | MLO | Class II | 2007-06-29 |
| K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A | Nihon Kohden America, Inc. | DRG | Class II | 2007-06-29 |
| K071226 | 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 | Spectranetics Corp. | PDU | Class II | 2007-06-29 |
| K071523 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750 | Genexel-Sein, Inc. | DXN | Class II | 2007-06-26 |
| K070791 | PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2007-06-26 |
| K071025 | ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO | Zoll Medical Corporation, World Wide Headquarters | MKJ | Class III | 2007-06-22 |
| K070159 | PRELUDE SHEATH INTRODUCER | Merit Medical Systems, Inc. | DRE | Class II | 2007-06-21 |
| K071020 | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE | GE Healthcare | MHX | Class II | 2007-06-18 |
| K071125 | AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 | Aga Medical Corp. | KRD | Class II | 2007-06-18 |
| K071042 | POLARCATH PERIPHERAL DILATATION SYSTEM | Boston Scientific Corp | LIT | Class II | 2007-06-13 |
| K062885 | STRIDE MICROCATHETER | Asahi Intecc Co., Ltd. | DQY | Class II | 2007-06-13 |
| K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | MHX | Class II | 2007-06-13 |
| K070403 | PRONTO .035 EXTRACTION CATHETER | Vascular Solutions, Inc. | QEZ | Class II | 2007-06-13 |
| K071047 | MASIMO PATIENT SAFETY NET | Masimo Corporation | MSX | Class II | 2007-06-08 |
| K070380 | PORTACLAMP FLEX | Cardio Life Research, S.A. | DXC | Class II | 2007-06-08 |
| K063008 | HEALTH CHECK KIOSK | Xperex Corporation | DXN | Class II | 2007-06-07 |
| K070395 | KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | Kodon(Tianjin)Electronic&Electrical Apparatus Co., | DXN | Class II | 2007-06-07 |
| K070417 | ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 | St Jude Medical | DYB | Class II | 2007-06-05 |
| K070951 | 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS | Boston Scientific | PNO | Class II | 2007-06-04 |
| K070566 | INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | MHX | Class II | 2007-06-04 |
| K071358 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | NCX | Class II | 2007-06-01 |
| K070372 | GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 | Vascular Solutions, Inc. | DQY | Class II | 2007-06-01 |
| K062149 | SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES | International Business Strategies | DQA | Class II | 2007-05-31 |
| K063042 | CARDIOMEM CM 3000-12BT | Getemed Medizin- Und Informationstechnik AG | MWJ | Class II | 2007-05-30 |
| K070014 | AUTO DETECT FOR TELAHEART DR200/E-A | North East Monitoring, Inc. | MWJ | Class II | 2007-05-25 |
| K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | Renu Medical, Inc. | NLF | Class II | 2007-05-25 |
| K071075 | TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A | Terumo Corp. | DXN | Class II | 2007-05-25 |
| K070408 | DURAMAX REUSABLE OXIMETRY SENSOR | Nellcor Puritan Bennett, Inc. | DQA | Class II | 2007-05-25 |
| K070825 | LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR | Little Doctor (Shanghai) Electronic Manufacturing | DXN | Class II | 2007-05-25 |
| K070456 | MICRUS COURIER ENZO MICROCATHETER 0.017 | Micrus Endovascular Corporation | DQO | Class II | 2007-05-24 |
| K062192 | OSTIAL PRO STENT POSITIONING SYSTEM | Ostial Solutions, LLC | DQX | Class II | 2007-05-24 |
| K070473 | BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX | Zen Strong Medical Technology Co., Ltd. | DXN | Class II | 2007-05-23 |
| K070286 | BIO-CONSOLE, MODEL 560 | Medtronic | DWA | Class II | 2007-05-22 |
| K070396 | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 | Acumen Medical, Inc. | DYB | Class II | 2007-05-22 |
| K071040 | WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS | Wright Linear Pump, Inc. | JOW | Class II | 2007-05-22 |
| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | Bard Access Systems, Inc. | DWM | Class II | 2007-05-18 |
| K071231 | EDAC QUANTIFIER | Luna Innovations, Inc. | KRL | Class II | 2007-05-17 |
| K071189 | CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER | Cordis Europa, N.V. | LIT | Class II | 2007-05-16 |
| K070242 | SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05 | Biosense Webster, Inc. | OBJ | Class II | 2007-05-15 |
| K070363 | FETCH ASPIRATION CATHETER | Possis Medical, Inc. | QEZ | Class II | 2007-05-11 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.