meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
49
Latest Decision
2014-11-25

Clearances · page 44 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133989 AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM Mortara Instrument, Inc. DXN Class II 2014-11-25
K141231 ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY Zeller Power Products (Battery Beast, LLC) MKJ Class III 2014-11-25
K142461 VASCU-GUARD Peripheral Vascular Patch Synovis Life Technologies, Inc. DXZ Class II 2014-11-25
K142065 TURNPIKE CATHETER Vascular Solutions, Inc. DQY Class II 2014-11-25
K142424 DR300 HOLTER MONITOR North East Monitoring, Inc. MWJ Class II 2014-11-25
K141682 TVC IMAGING SYSTEM, TVC INSIGHT CATHETER Infraredx, Inc. OGZ Class II 2014-11-24
K142681 ZEUS (ZIO ECG Utilization Service) System iRhythm Technologies, Inc. DQK Class II 2014-11-21
K133997 LG SMARTHEALTH Lg Electronics DRG Class II 2014-11-21
K142183 GLIDESHEATH SLENDER Terumo Medical Corporation DYB Class II 2014-11-21
K143038 Gel-Block 10X embolization pledgets Vascular Solutions, Inc. KRD Class II 2014-11-20
K142062 SPIRAL FLOW PERIPHERAL VASCULAR GRAFT Vascular Flow Technologies, Ltd. DSY Class II 2014-11-20
K141774 ZOLL X SERIES ZOLL Medical Corporation MKJ Class III 2014-11-19
K140910 CENTERCROSS CATHETER Roxwood Medical, Inc. DQY Class II 2014-11-19
K140497 ECVUE MAPPING SYSTEM Cardioinsight Technologies, Inc. DQK Class II 2014-11-19
K141755 ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR Sejoy Electronics & Instruments Co., Ltd. DXN Class II 2014-11-19
K141811 MORTARA MONITORING WAVEFORM VIEWER Mortara Instrument, Inc. MHX Class II 2014-11-19
K140569 ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) Maquet Cardiopulmonary, AG DWF Class II 2014-11-19
K142673 Bio-Medicus Adult Cannulae and Introducer Medtronic, Inc. DWF Class II 2014-11-18
K141390 INTERMITTENT PNEUMATIC COMPRESSION DEVICE Wuhan Landing Medical Hi-Tech, Ltd. JOW Class II 2014-11-18
K142601 Panorama Patient Monitoring Network Shenzhen Mindray Bio-Medical Electronics Co. MHX Class II 2014-11-14
K141617 CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical, L.P. QEW Class II 2014-11-14
K140438 MICRO GUIDE CATHETER ELITE Cordis Corp., A Johnson & Johnson Co. PDU Class II 2014-11-14
K142565 Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter Stryker Neurovascular DQY Class II 2014-11-14
K140078 TECOTHERM NEO (T NEO) Inspiration Healthcare, Ltd. DWJ Class II 2014-11-14
K140466 PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 St. Jude Medical Systems AB DXO Class II 2014-11-13
K142265 ONE Snare Endovascular Microsnare System Merit Medical Systems, Inc. MMX Class II 2014-11-13
K142254 CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector St Jude Medical DQX Class II 2014-11-13
K142593 AngioVac Cannula AngioDynamics, Inc. DWF Class II 2014-11-12
K142301 Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath Cook Vascular, Inc. DRE Class II 2014-11-12
K140502 ZOLL E SERIES ALS ZOLL Medical Corporation LDD Class II 2014-11-06
K142640 Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator Bio Compression Systems, Inc. JOW Class II 2014-11-06
K142684 FlexCath Select Steerable Sheath (10 French) Medtronic Cryocath, LP DYB Class II 2014-11-06
K141649 SPEX SUPPORT CATHETER Reflow Medical DQY Class II 2014-11-05
K142489 Unimed Disposable ECG lead wires Unimed Medical Supplies, Inc. DSA Class II 2014-11-04
K142088 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES Grandway Technology (Shenzhen) Limited DXN Class II 2014-10-31
K133810 VC150 VITAL SIGNS MONITOR Innokas Yhtyma MWI Class II 2014-10-30
K142199 Ascendra Balloon Aortic Valvaloplasty Catheter Edwards Lifesciences OZT Class II 2014-10-29
K142245 EpiAccess System Epiep, Inc. DYB Class II 2014-10-29
K140020 HYPERQ ACS-100 SYSTEM Bsp-Biiological Signal Processing, Ltd. DPS Class II 2014-10-28
K142654 Fortrex 0.035 OTW PTA Balloon Catheter Covidien, LLC LIT Class II 2014-10-28
K141686 EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY Smith Medical Asd, Inc. DWJ Class II 2014-10-28
K141809 RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM Defibtech, LLC DRM Class II 2014-10-27
K142784 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface Medtronic, Inc. DTZ Class II 2014-10-24
K141175 RENOVOCATH RC120 Renovorx, Inc. MJN Class II 2014-10-24
K141339 ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE Asahi Intecc Co., Ltd. DQX Class II 2014-10-23
K142359 Vasc Band hemostat Lepu Medical Technology (Beijing) Co., Ltd. DXC Class II 2014-10-23
K133157 TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 Medtronic, Inc. DRY Class II 2014-10-23
K141491 SOLITAIRE 2 REVASCULARIZATION DEVICE Micro Therapeutics, Inc. d/b/a ev3 Neurovascular NRY Class II 2014-10-22
K142660 Antegrade LeMills Valvulotome LeMaitre Vascular, Inc. MGZ Class II 2014-10-17
K141801 HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM Covidien, LLC MCW Class II 2014-10-16
K140543 PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER Merit Medical Systems, Inc. DYB Class II 2014-10-16
K142014 SOFIA DISTAL ACCESS CATHETER MicroVention, Inc. DQY Class II 2014-10-10
K133441 ONESTEP CPR II MULTI-FUNCTION ELECTRODE Bio-Detek, Inc. MKJ Class III 2014-10-10
K141416 BLOOD PRESSURE MONITOR Shenzhen Pump Medical System Co., Ltd. DXN Class II 2014-10-09
K132592 FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET Cook, Inc. DYB Class II 2014-10-09
K140805 ITCLAMP 50 Innovative Trauma Care, Inc. DXC Class II 2014-10-09
K141378 IDC INTERLOCKING DETACHABLE COIL Boston Scientific Corporation KRD Class II 2014-10-08
K141201 A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR A & D Co., Ltd. DXN Class II 2014-10-08
K141160 A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR A & D Co., Ltd. DXN Class II 2014-10-07
K141139 SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER Zoll Circulation NCX Class II 2014-10-03
K141542 NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) Covidien, LLC DQA Class II 2014-10-02
K141547 WINGMAN EXTENDABLE TIP SUPPORT CATHETER Reflow Medical DQY Class II 2014-09-30
K141113 SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE Spacelabs Healthcare, Ltd. DXN Class II 2014-09-26
K142546 TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath Spectranetics, Inc. DRE Class II 2014-09-25
K141150 PTA BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 2014-09-25
K142261 Ultraverse 035 PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc. LIT Class II 2014-09-24
K141483 BIOSPACE BODY COMPOSITION ANALYZER Biospace Corporation Limited MNW Class II 2014-09-23
K141453 ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER Lightlab Imaging, Inc. DQO Class II 2014-09-19
K133852 APOLLO BALLOON DILATATION CATHETER Brosmed Medical LOX Class II 2014-09-19
K141998 SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS Pinghu Sama Medical Packing Co., Ltd. DXQ Class II 2014-09-19
K133753 MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR Infobionic, Inc. QYX Class II 2014-09-19
K141696 EDWARDS ESHEATH INTRODUCER SET Edwards Lifesciences DYB Class II 2014-09-18
K141985 TRUE BA V BALLOON VALVULOPLASTY CATHETER C.R. Bard, Inc. OZT Class II 2014-09-18
K140557 MIVI 6F GUIDE CATHETER Mivi, LLC DQY Class II 2014-09-18
K134035 TRANSONIC HCM 103 SYSTEM Transonic Systems, Inc. DXG Class II 2014-09-17
K142300 Arrow GPSCath Balloon Dialation Catheter (150 cm) Hotspur Technologies, Inc., LIT Class II 2014-09-17
K140017 TRANSONIC HCM 102 SYSTEM Transonic Systems, Inc. DXG Class II 2014-09-16
K140928 ABPM7100 I.E.M. GmbH DXN Class II 2014-09-15
K141025 ARTIMES BALLOON DILATATION CATHETER Brosmed Medical LOX Class II 2014-09-12
K140608 MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE Merit Medical Systems, Inc. DQX Class II 2014-09-12
K133983 INTRA. OX HANDHELD TISSUE OXIMETER Vioptix, Inc. MUD Class II 2014-09-12
K142259 Direxion Torqueable Microcatheter Boston Scientific Corp KRA Class II 2014-09-10
K141156 SPACELABS HEALTHCARE TELEMETRY RECEIVER Spacelabs Healthcare MHX Class II 2014-09-09
K142182 FRIMAP ADAPTER CONNECTOR (MAC) Topera, Inc. MTD Class II 2014-09-09
K141706 ECARE COORDINATOR (ECC) Visicu, Inc. DRG Class II 2014-09-09
K141924 HD BLOOD PRESSURE MONITOR Biocare Asia Corporation , Ltd. DXN Class II 2014-09-08
K142105 ELI 380 ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2014-09-05
K141831 HYDRAVIEW GUIDEWIRE Brivant Limited DQX Class II 2014-09-04
K141495 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER Edwards Lifesciences, LLC DXO Class II 2014-09-03
K140804 VDRIVE WITH V-LOOP/ VDRIVE DUO Stereotaxis, Inc. DXX Class II 2014-09-03
K140874 GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF Shanghai Goahui Rubber and Plastic Company DXQ Class II 2014-09-02
K142221 MEMO 3D ReChord Sorin Group Italia S.R.L. KRH Class II 2014-08-29
K132943 INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE Synaptic Medical Limited DRC Class II 2014-08-29
K140582 FINGERTIP PULSE OXIMETER Shenzhen Jumper Medical Equipment Co., Ltd. DQA Class II 2014-08-28
K140338 CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) Creganna-Tactx Medical DYB Class II 2014-08-27
K133023 JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 Medrad, Inc. MCW Class II 2014-08-27
K140944 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP Atheromed, Inc. MCW Class II 2014-08-22
K141083 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR Microlife Intellectual Property GmbH DXN Class II 2014-08-22
K141521 MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER Boston Scientific Corporation LIT Class II 2014-08-21
K140028 GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER Galt Medical Corp. DYB Class II 2014-08-21

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