meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
2012-06-29

Clearances · page 54 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K120193 ANY VIEW PATIENT MONITORS Guangdong Biolight Meditech Co., Ltd. MWI Class II 2012-06-29
K113459 ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING Edwards Lifesciences, LLC DWF Class II 2012-06-29
K121175 FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM Ostial Corporation LIT Class II 2012-06-29
K121527 WI-FI BODY SCALE Shenzhen Healthcare Electronic Technology Co., Ltd. MNW Class II 2012-06-28
K113835 DATACAPTOR SYSTEM Capsule Tech, Inc. MWI Class II 2012-06-27
K120780 EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE Edwards Lifesciences, LLC DWF Class II 2012-06-27
K121681 GLIDER PTCA BALLOON CATHETER Trireme Medical, Inc. LOX Class II 2012-06-26
K121222 TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER Abbott Vascular LOX Class II 2012-06-22
K121532 HERO GRAFT Hemosphere, Inc. DSY Class II 2012-06-22
K121367 ZOLL PROPAQ XM ZOLL Medical Corporation MHX Class II 2012-06-21
K121521 AXERA ACCESS SYSTEM Arstasis, Inc. DYB Class II 2012-06-21
K121470 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR Andon Health Co, Ltd. DXN Class II 2012-06-14
K121677 SUREFIRE HI-FLOW MICROCATHETER Surefire Medical, Inc. DQO Class II 2012-06-14
K113008 KODAMA INTRAVASCULAR ULRASOUND CATHETER Silicon Vally Medical Instruments, Inc. OBJ Class II 2012-06-14
K111048 SYNTHES SCOUT TACK FIXATION Synthes Spine OMR Class II 2012-06-14
K121442 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Cordis Corporation LIT Class II 2012-06-14
K121385 VECTOR R4 Vascular, Inc. LIT Class II 2012-06-14
K121424 EXPRESSION INFORMATION PORTAL Invivo Corporation MWI Class II 2012-06-13
K121051 CONCIERGE GUIDING CATHETER Merit Medical Systems, Inc. DQY Class II 2012-06-13
K113628 AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES Catheter Robotics, Inc. DXX Class II 2012-06-12
K121145 RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME Renu Medical, Inc. JOW Class II 2012-06-12
K113658 AMPLATZER VASCULAR PLUG 4 Aga Medical Corp. KRD Class II 2012-06-12
K113411 EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA Edwards Lifesciences, LLC DWF Class II 2012-06-11
DEN080015 NUCLEUS-X PTV CATHETER NuMED, Inc. OZT Class II 2012-06-11
K121402 CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G Trireme Medical, Inc. LIT Class II 2012-06-08
K120164 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE Angioslide, Ltd. LIT Class II 2012-06-08
K120470 MIPAL Watermark Medical DRG Class II 2012-06-08
K120624 ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) Elcam Medical Acal DRS Class II 2012-06-08
K120808 EXPORT XT CATHETER, EXPORT AP CATHETER Medtronic, Inc. QEZ Class II 2012-06-07
K121480 ARIATELE TELEMETRY TRANSMITTER (96281) Spacelabs Healthcare MHX Class II 2012-06-06
K120987 DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF Medtronic, Inc. DWF Class II 2012-06-06
K113363 ANGIOJET SOLENT DISTA THROMBECTOMY SET Medrad, Inc. QEZ Class II 2012-06-06
K120346 CLEANER ROTATIONAL THROMBECTOMY SYSTEM Rex Medical MCW Class II 2012-06-01
K120672 KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2012-06-01
K120944 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER Covidien JOW Class II 2012-05-31
K120543 TANDEMHEART FEMORAL ARTERIAL CANNULA SET Cardiacassist, Inc. DWF Class II 2012-05-30
K113402 SOLOHEALTH STATION Solohealth, Inc. DXN Class II 2012-05-30
K111004 HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER Hansen Medical, Inc. DXX Class II 2012-05-29
K120612 MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT Medtronic, Inc. DWF Class II 2012-05-25
K120964 UPSTREAM GR CATHETER Upstream Peripheral Technologies DQY Class II 2012-05-25
K120631 PATIENT MONITOR Advanced Instruments, Inc. MHX Class II 2012-05-25
K120895 REMOTE PRESENCE SYSTEM Intouch Health, Inc. DRG Class II 2012-05-24
K120425 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER Biosense Webster, Inc. MTD Class II 2012-05-24
K113103 SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE Rex Medical PNO Class II 2012-05-22
K120533 BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES Bridgepoint Medical PDU Class II 2012-05-22
K121265 AMPHIRION PLUS PTA CATHETER Medtronic, Inc. LIT Class II 2012-05-22
K120495 IMPULSE AND EXPO ANGIOGRAPHIC CATHETER Boston Scientific Corp DQO Class II 2012-05-21
K121009 HEARTCHECK ECG PEN WITH GEMS HOME Cardiocomm Solutions, Inc. DPS Class II 2012-05-17
K120173 PATIENT MONITOR Edan Instruments, Inc. MHX Class II 2012-05-16
K112921 MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM Medicalgorithmics S.A. DSI Class II 2012-05-16
K121141 TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM Tensys Medical Systems, Inc. DXN Class II 2012-05-15
K120707 SWITCH-IT CATHETER Vascular Solutions, Inc. DQY Class II 2012-05-15
K113266 GEL-BLOCK EMBOLIZATION PLEDGETS Vascular Solutions, Inc. KRD Class II 2012-05-14
K113215 MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY Nonin Medical, Inc. MUD Class II 2012-05-14
K120296 CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER St. Jude Medical, Cardiac Rhythm Management Divisi DQY Class II 2012-05-11
K120185 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR Sorin Group Italia S.R.L. DTZ Class II 2012-05-11
K120119 SUNMED GUIDE WIRE Sunny Medical Device (Shenzhen) Co., Ltd. DQX Class II 2012-05-11
K112660 POCKETCPR Zoll Medical Corp LIX Class II 2012-05-10
K121209 TERUMO PALL AL20X ARTERIAL FILTER Terumo Cardiovascular Systems Corporation DTM Class II 2012-05-08
K120072 VENOUS DRAINAGE CANNULA WITH DURAFLO COATING Edwards Lifesciences, LLC DWF Class II 2012-05-08
K120298 CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE St. Jude Medical, Cardiac Rhythm Management Divisi DQX Class II 2012-05-08
K120550 CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) Biosense Webster, Inc. DQK Class II 2012-05-07
K112797 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER Cordis Corp. LIT Class II 2012-05-04
K121015 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM Abbott Vascular NTE Class II 2012-05-04
K120364 UNIMED DISPOSABLE BLOOD PRESSURE CUFF Unimed Medical Supplies, Inc. DXQ Class II 2012-05-04
K121057 COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS William Cook Europe Aps DTK Class II 2012-05-04
K121006 ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER St Jude Medical MTD Class II 2012-05-03
K120704 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM 3M Company DRG Class II 2012-05-03
K113833 VITAL SIGNS MONITOR Guangdong Biolight Meditech Co., Ltd. MWI Class II 2012-05-01
K120492 K2 MEDICAL VASCULAR CLAMPS K2 Medical GmbH & Co. KG DXC Class II 2012-04-30
K112761 ZOLL PROPAQ MD Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2012-04-25
K113485 ELECTROCARDIOGRAPH Shenzhen Carewell Electronics Co., Ltd. DPS Class II 2012-04-25
K120086 CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM Cardiosolutions DRA Class II 2012-04-24
K120428 GORE DRYSEAL SHEATH W. L. Gore & Associates, Inc. DYB Class II 2012-04-20
K120868 MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER Datascope Corp., Cardiac Assist Division DSP Class II 2012-04-20
K113778 EXCELSIOR XT-27 MICROCATHETER Stryker Neurovascular DQY Class II 2012-04-20
K112843 PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2012-04-19
K120863 WHOLEY GUIDE WIRE SYSTEM Covidien, LLC DQX Class II 2012-04-19
K120971 ATLAS PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. LIT Class II 2012-04-19
K120722 RIVAL PTA DILATATION CATHETER Bard Peripheral Vascular, Inc. LIT Class II 2012-04-19
K120881 MANTARAY GUIDEWIRES Bridgepoint Medical DQX Class II 2012-04-18
K121001 COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) Novitas Medical, LLC JOW Class II 2012-04-17
K120816 INZONE DETACHMENT SYSTEM Stryker KRD Class II 2012-04-17
K120972 FLEXITOUCH SYSTEM Tactile Systems Technology, Inc. JOW Class II 2012-04-13
K120805 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE Angioslide, Ltd. LIT Class II 2012-04-13
K112398 TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT Galt Medical DYB Class II 2012-04-12
K120774 ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT Welch Allyn, Inc. DSI Class II 2012-04-10
K112149 WEIGHT AND BODY FAT SCALE SHINE BS0105 Shine Overseas Marketing Limited MNW Class II 2012-04-09
K120349 SONIXGPS VASCULAR ACCESS NEEDLE KIT Ultrasonix Medical Corpation DRE Class II 2012-04-09
K120697 EAGLE EYE PLATINUM ST CATHETER Volcano Corporation OBJ Class II 2012-04-05
K113626 INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR Sorin Group Italia S.R.L. DTZ Class II 2012-04-05
K120204 REPROCESSED FEMORAL COMPRESSION DEVICE Sterilmed, Inc. NMF Class II 2012-04-03
K113144 PAGEWRITER TC 20, 30, 50, 70 Philips Medical Systems DPS Class II 2012-04-03
K120694 ENCORE 26 ADVANTAGE KIT Boston Scientific Corp MAV Class II 2012-04-03
K120069 MEDLINE STOPCOCK AND MANIFOLD Medline Industries, Inc. DTL Class II 2012-04-03
K112452 ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS AngioDynamics, Inc. DQO Class II 2012-03-30
K120273 KITTYCAT CATHETER, KITTYCAT 2 CATHETER Avinger, Inc. PDU Class II 2012-03-30
K112119 CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH William Cook Europe Aps DTK Class II 2012-03-30
K120616 SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 Spacelabs Medical, Inc. MHX Class II 2012-03-29
K120893 IMAGER II ANGIOGRAPHIC CATHETERS Boston Scientific Corp DQO Class II 2012-03-29

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