meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
2013-03-13

Clearances · page 51 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K130333 CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR Terumo Cardiovascular Systems Corp. DTZ Class II 2013-03-13
K130520 CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR Ashitaka Factory of Terumo Corp. DTZ Class II 2013-03-13
K130359 CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA Terumo Cardiovascular Systems Corp. DTZ Class II 2013-03-13
K130153 HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST Philips Medical Systems MKJ Class III 2013-03-12
K123073 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 Grandway Technology (Shenzhen) Limited DXN Class II 2013-03-11
K121825 CS-MAG II Biomagnetik-Park GmbH DPS Class II 2013-03-11
K122306 SYNOVIS COLLAGEN MATRIX (TBD) Synovis Surgical Innovations DXZ Class II 2013-03-08
K122469 ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ Asahi Intecc Co., Ltd. DQX Class II 2013-03-08
K123228 INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) Biospace Corporation Limited MNW Class II 2013-03-08
K122468 ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO Asahi Intecc Co., Ltd. DQX Class II 2013-03-08
K124007 SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY Micro Therapeutics, Inc. D/B/A: Ev3, Inc. DQX Class II 2013-03-07
K123694 SAM JUNCTIONAL TOURNIQUET Sam Medical Products DXC Class II 2013-03-07
K124039 HERO GRAFT Hemoshpere, Inc., A Cryolife Company DSY Class II 2013-03-07
K123837 PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc. MTD Class II 2013-03-05
K123472 CIMVA UNIVERSAL Therapeutic Monitoring Systems (Tms), Inc. MHX Class II 2013-03-05
K130307 ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE Celonova Biosciences, Inc. KRD Class II 2013-03-04
K123818 URSA ANGIOGRAPHIC CATHETER Curative Medical Technology, Inc. DQO Class II 2013-03-04
K123780 TRANSTEK BLOOD PRESSURE MONITOR Zhongshan Transtek Electronics Co., Ltd. DXN Class II 2013-03-01
K130155 MUSE CARDIOLOGY INFORMATION SYSTEM Ge Medical Systems Information Technologies, Inc. DQK Class II 2013-03-01
K122590 RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE Terumo Medical Corporation DQX Class II 2013-03-01
K123959 CIRCUFLOW 5150 Devon Medical, Inc. JOW Class II 2013-02-28
K123707 ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE Cook, Inc. DQX Class II 2013-02-28
K123002 VITAL SYNC SYSTEM Covidien, Formerly Nellcor Puritan Bennett, Inc. MWI Class II 2013-02-27
K123816 DIGITAL ELECTROCARDIOGRAPHS Shenzhen Biocare Electronics Co., Ltd. DPS Class II 2013-02-27
K123187 RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA Edwards Lifesciences, LLC DWF Class II 2013-02-22
K124061 MRI PATIENT MONITORING SYSTEM (MODEL 865214) Invivo Corporation MWI Class II 2013-02-22
K122640 VPULSE Cothera, LLC JOW Class II 2013-02-22
K124060 MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM Medicalgorithmics S.A. DSI Class II 2013-02-21
K123974 PERCUTANEOUS INTRODUCER KIT Teleflex, Inc. DYB Class II 2013-02-21
K122184 ECG CHECK Cardiac Designs, LLC DXH Class II 2013-02-14
K123235 EQUAFLOW MULTIVALVE INFUSION CATHETER Cook Incorporated DYB Class II 2013-02-14
K123647 CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE Devon Medical, Inc. JOW Class II 2013-02-14
K120673 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES Grandway Technology (Shenzhen) Limited DXN Class II 2013-02-14
K120675 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES Grandway Technology (Shenzhen) Limited DXN Class II 2013-02-14
K130209 INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED Sorin Group Italia S.R.L. DTZ Class II 2013-02-12
K123544 RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER Ev3, Inc. LIT Class II 2013-02-12
K123308 PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM Albahealth, LLC JOW Class II 2013-02-08
K122810 COMPACT DIGITAL BLOOD PRESSURE MONITOR Thermor , Ltd. DXN Class II 2013-02-08
K123216 AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN Aimago SA DPT Class II 2013-02-07
K122587 BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208 St Jude Medical DRC Class II 2013-02-07
K123217 CARDEASCREEN Cardea Associates, Inc. DPS Class II 2013-02-05
K130016 LIFESPAN EPTFE VASCULAR GRAFT LeMaitre Vascular, Inc. DSY Class II 2013-02-05
K122046 WRIST PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2013-02-04
K123033 ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B Rocket Medical Plc DWM Class II 2013-02-01
K123111 V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc. OZT Class II 2013-01-31
K123279 MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN Abbott Vascular LOX Class II 2013-01-30
K123067 PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY Abbott Vascular, Inc. DQX Class II 2013-01-29
K122431 HEARTSPAN STEERABLE INTRODUCER KIT Thomas Medical Products, Inc. DYB Class II 2013-01-29
K123358 PACIFIC PLUS Medtronic Vascular LIT Class II 2013-01-29
K123135 AXERA 2 ACCESS SYSTEM MODEL AXE200 Arstasis, Inc. DYB Class II 2013-01-28
K123632 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 Spectranetics Corp. MCW Class II 2013-01-25
K121860 ESA615 Fluke Biomedical DRT Class II 2013-01-25
K122926 SUREFLEX STEERABLE GUIDING SHEATH KIT Baylis Medical Co., Inc. DYB Class II 2013-01-24
K123334 REPROCESSED STEERABLE INTRODUCER Stryker Sustainability Solutions, Inc. DYB Class II 2013-01-24
K123314 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE Medtronic, Inc. DTZ Class II 2013-01-22
K123813 VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE Vasonova, Inc. OBJ Class II 2013-01-18
K122585 CRUX VENA CAVA FILTER SYSTEM Crux Biomedical DTK Class II 2013-01-17
K123946 WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS Cincinnati Sub-Zero Products, Inc. DWJ Class II 2013-01-17
K123671 WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM Sanitas, Inc. DRG Class II 2013-01-16
K123609 MERIT HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc. DQX Class II 2013-01-16
K123264 DK-PTCA BALLOON CATHETER Intuit Medical, LLC LOX Class II 2013-01-16
K122873 VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS Caremed Supply, Inc. JOW Class II 2013-01-15
K123311 QXMEDICAL ACCESS & SUPPORT CATHETER Qxmedical, LLC DQY Class II 2013-01-14
K123839 WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200 Ningbo Diaier Electronic Co., Ltd. DXN Class II 2013-01-11
K123324 SELECTRA 7F CATHETERS Biotronik, Inc. DQY Class II 2013-01-11
K122878 HD-IVUS ULTRASOUND IMAGING SYSTEM Silicon Vally Medical Instruments, Inc. OBJ Class II 2013-01-11
K123048 PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO Advanced Instrumentations, Inc. MHX Class II 2013-01-11
K122685 ANGIOSCULPT PTA SCORING BALLOON CATHETER Angioscore, Inc. PNO Class II 2013-01-11
K122576 TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT Stryker Neurovascular MJN Class II 2013-01-11
K122914 AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE Medtronic, Inc. DTN Class II 2013-01-09
K123781 TRANSTEK GLASS BODY FAT ANALYZER Zhongshan Transtek Electronics Co., Ltd. MNW Class II 2013-01-09
K122976 BODY FAT SCALE MODEL SF-371 Shenzhen Belter Health Measurement and Analysis TE MNW Class II 2013-01-04
K113787 DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC MKJ Class III 2013-01-04
K122854 ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER Arrow International (Subsidiary of Teleflex Inc.) DYB Class II 2013-01-04
K123194 JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088 North American Rescue Products, Inc. DXC Class II 2013-01-03
K123452 TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM Stryker DQY Class II 2013-01-03
K122943 MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER Moor Instruments, Ltd. DPT Class II 2013-01-03
K121108 DOPPLEX ABILITY Huntleigh Healthcare JOM Class II 2013-01-03
K123712 RETRACTA DETACHABLE EMBOLIZATION COIL Cook Incorporated KRD Class II 2013-01-03
K123591 FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) Medtronic Cryocath, LP DRA Class II 2012-12-27
K123669 TRANSTEK WRIST BLOOD PRESSURE MONITOR Zhongshan Transtek Electronics Co., Ltd. DXN Class II 2012-12-21
K121077 NHANCER Imds Operations B.V. DQY Class II 2012-12-21
K122609 VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F Venous Health Systems, Inc. JOW Class II 2012-12-21
K123466 HEALTHVIEW ECG MANAGER Lumedx DQK Class II 2012-12-20
K122927 OXICARE FINGERTIP PULSE OXIMETER Delbio Incorporated DQA Class II 2012-12-20
K121913 REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER Stryker Sustainability Solutions, Inc. OWQ Class II 2012-12-20
K122321 BASIXCONPAK ANALOG INFLATION SYRINGE Merit Medical Ireland, Ltd. MAV Class II 2012-12-19
K122832 MOBICATH TRANSSEPTAL NEEDLE Great Batch Medical DRC Class II 2012-12-19
K122813 HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM Cincinnati Sub-Zero Products, Inc. DWC Class II 2012-12-18
K122152 OXTI INFLATION DEVICE Oxti Corporation MAV Class II 2012-12-14
K123532 OCELOT PIXL CATHETER Avinger, Inc. PDU Class II 2012-12-14
K122827 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 Medtronic, Inc. DTZ Class II 2012-12-14
K123531 UNBALLOON NON-OCCLUSIVE MODELING CATHETER LeMaitre Vascular, Inc. DQY Class II 2012-12-14
K122937 SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) Cook, Inc. DQO Class II 2012-12-14
K122958 DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY Oscor, Inc. DYB Class II 2012-12-13
K121398 CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) Guidepath Medical, Inc. DQX Class II 2012-12-13
K123448 AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE Medtronic, Inc. DTL Class II 2012-12-13
K121853 DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES Defibtech, LLC MKJ Class III 2012-12-13
K122839 ZOLL SUREPOWER SINGLE BAY CHARGER ZOLL Medical Corporation MKJ Class III 2012-12-13
K122960 STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO Oscor, Inc. DYB Class II 2012-12-13

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