meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
50
Latest Decision
2012-12-13

Clearances · page 52 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K123156 GORE FLOW REVERSAL SYSTEM MODEL GFRS073 W. L. Gore & Associates, Inc. NTE Class II 2012-12-13
K121266 CARDIOSCOPE Pulsecor Limited DXN Class II 2012-12-11
K122980 GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ Terumo Medical Corporation DYB Class II 2012-12-11
K122684 REVERSE MEDICAL MICROCATHETER Reverse Medical Corporation DQY Class II 2012-12-07
K123462 OCELOT CATHETER Avinger, Inc. PDU Class II 2012-12-07
K122105 SMI CARDIOVASCULAR PATCH Solinas Medical, Inc. DXZ Class II 2012-12-07
K122330 FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE Arjohuntleigh Polska SP Z.O.O. JOW Class II 2012-12-07
K120502 PC-60NW FINGERTIP OXIMETER Shenzhen Creative Industry Co., Ltd. DQA Class II 2012-12-07
K123446 TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM United States Gtm Medical Devices, Inc. DXN Class II 2012-12-07
K122760 AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE Medtronic, Inc. DTM Class II 2012-12-07
K120770 QT GUARD PLUS ANALYSIS SYSTEM Ge Medical Systems Information Technologies DPS Class II 2012-12-06
K122645 MOBILE CAREGUIDE 2100 OXIMETER Reflectance Medical, Inc. MUD Class II 2012-12-05
K122088 MERIT ONE SNARE SYSTEM Merit Medical Systems, Inc. MMX Class II 2012-12-05
K123378 SOLITAIRE 2 REVASCULARIZATION DEVICE Micro Therapeutics Dba Ev3 Neurovascular NRY Class II 2012-11-30
K123035 SEAL ONE Perouse Medical DXC Class II 2012-11-28
K123020 BLIP MODEL BP-700WF Carematix, Inc. DXN Class II 2012-11-28
K122543 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 MicroVention, Inc. KRD Class II 2012-11-28
K122161 SJM CONFIRM St Jude Medical MXC Class II 2012-11-28
K123384 AZUR CX DETACHABLE 18 MicroVention, Inc. KRD Class II 2012-11-28
K121763 MULTICROSS SUPPORT CATHETER Roxwood Medical, Inc. DQY Class II 2012-11-27
K122581 MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 Concentric Medical, Inc. DQY Class II 2012-11-21
K121865 ZOLL RESCUENET 12-LEAD ZOLL Medical Corporation MSX Class II 2012-11-20
K121234 GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING W. L. Gore & Associates, Inc. DYB Class II 2012-11-20
K122573 HI-TORQUE COMMAND GUIDE WIRE FAMILY Abbott Vascular, Inc. DQX Class II 2012-11-20
K122772 PENUMBRA DDC CATHETERS Penumbra, Inc. DQY Class II 2012-11-20
K122443 UFIT TEN-10 Biosign Technologies, Inc. DXN Class II 2012-11-20
K122488 AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES Catheter Robotics, Inc. DXX Class II 2012-11-20
K123039 CDI BLOOD PARAMETER MONITORING SYSTEM 500 Terumo Cardiovascular Systems Corp. DRY Class II 2012-11-20
K121712 AIRSTRIP RPM FOR LIFENET CONSULT Airstrip Technologies, Inc. MSX Class II 2012-11-20
K123229 REMOTE PRESENCE SYSTEM, MODEL RP-VITA Intouch Health, Inc. DRG Class II 2012-11-20
K120617 PTFE SUPER SHEATH INTRODUCER Martech Medical Products DYB Class II 2012-11-19
K122333 MOBILECARE MONITOR Aframe Digital, Inc. DRG Class II 2012-11-19
K122356 ALIVECOR HEART MONITOR FOR IPHONE AliveCor, Inc. DPS Class II 2012-11-19
K122129 SPHYGMOCOR XCEL Atcor Medical DXN Class II 2012-11-16
K122090 SJM CONFIRM IMPLANTABLE CARDIAC MONITOR St. Jude Medical, Cardiac Rhythm Management Divisi MXC Class II 2012-11-15
K112830 ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) Noninvasive Medical Technologies, Inc. DSB Class II 2012-11-13
K123214 ENCORE 26 ADVANTAGE KIT Boston Scientific Corp MAV Class II 2012-11-13
K113124 ALN OPTIONAL VANA CAVA FILTER Aln Implants Chirurgicaux DTK Class II 2012-11-09
K122405 AIR-BAND RADIAL COMPRESSION DEVICE Datascope Corp., Cardiac Assist Division DXC Class II 2012-11-09
K122795 STINGRAY GUIDEWIRES Bridgepoint Medical DQX Class II 2012-11-08
K112877 COMEN MULTI-PARAMETER PATIENT MONITOR Goldway (Us), Inc. MWI Class II 2012-11-07
K120508 CLEARLUMEN THROMBECTOMY SYSTEM Walk Vascular, LLC QEZ Class II 2012-11-07
K122380 OCELOT SYSTEM Avinger, Inc. PDU Class II 2012-11-07
K122058 FLEXIPORT ECOCUFF Welch Allyn, Inc. DXQ Class II 2012-11-05
K122401 TANGO M2 BLOOD PRESSURE MONITOR Suntech Medical, Inc. DXN Class II 2012-11-02
K112735 TAMARIN BLUE PTCA RX DILATATION CATHETER Natec Medical , Ltd. LOX Class II 2012-11-02
K122367 BARD PTV DILATATION CATHETER C.R. Bard, Inc. OMZ Class II 2012-11-02
K120350 EXTENDED LIFE BATTERY Aed Battery Exchange, LLC MKJ Class III 2012-11-01
K122478 MODIFIED TREVO RETRIEVER Concentric Medical, Inc. NRY Class II 2012-10-31
K120406 ZOLL FULLY AUTOMATIC AED PLUS Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2012-10-26
K123024 TORQUE DEVICE Boston Scientific Corporation DQX Class II 2012-10-26
K122712 DIGITAL ELECTROCARDIOGRAPH Shenzhen Biocare Electronics Co., Ltd. DPS Class II 2012-10-25
K122987 STEALTH 360 ORBITAL PAD SYSTEM Cardiovascular Systems, Inc. MCW Class II 2012-10-25
K120545 HX-461 Seers Technology Co., Ltd. DXN Class II 2012-10-23
K122984 ATLAS GOLD PTA DILATATION CATHETER C.R. Bard, Inc. LIT Class II 2012-10-22
K122050 CPRMETER CPR FEEDBACK DEVICE Laerdal Medical A/S LIX Class II 2012-10-22
K122482 TRANSTEK WRIST BLOOD PRESSURE MONITOR Zhongshan Transtek Electronics Co., Ltd. DXN Class II 2012-10-22
K122913 AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 Medtronic, Inc. DWF Class II 2012-10-19
K122916 JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM Medrad, Inc. MCW Class II 2012-10-19
K121962 PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B Mego Afek AC , Ltd. JOW Class II 2012-10-19
K122499 AIRCAST VENAFLOW ELITE SYSTEM Djo, LLC JOW Class II 2012-10-18
K121849 PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE Care Fusion DWM Class II 2012-10-18
K122856 CHARTER GUIDEWIRE Brivant, Ltd. DQX Class II 2012-10-17
K122844 INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR Sorin Group Italia S.R.L. DTZ Class II 2012-10-17
K121697 FINGERTIP PULSE OXIMETER Andon Health Co, Ltd. DQA Class II 2012-10-15
K122811 CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE Medtronic, Inc. DTL Class II 2012-10-12
K122178 FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1 Ostial Corporation LOX Class II 2012-10-11
K121083 TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA Loma Vista Medical OZT Class II 2012-10-11
K121722 ESA620 ELECTRICAL SAFETY ANALYZER Fluke Biomedical DRT Class II 2012-10-11
K122600 LIFEPAK 1000 DEFIBRILLATOR Physio-Control, Inc. MKJ Class III 2012-10-11
K122796 CXI SUPPORT CATHETER Cook, Inc. KRA Class II 2012-10-11
K112826 NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR Moor Instruments, Ltd. MUD Class II 2012-10-10
K122012 Z-MED Z-MED II NuMED, Inc. OZT Class II 2012-10-04
K120125 SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF Ge Medical Systems Information Technologies, Inc. DXQ Class II 2012-10-03
K122133 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING Airstrip Technologies, LP MWI Class II 2012-10-02
K121806 BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE Covidien DQA Class II 2012-09-28
K121971 WITHINGS, SMART BODY SCALE Zhongshan Transtek Electronics Co., Ltd. MNW Class II 2012-09-27
K121504 SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS Togo Medikit Co., Ltd. DYB Class II 2012-09-27
K121144 ELECTRONIC STETHOSCOPE Sharp Corporation DQD Class II 2012-09-26
K120907 ZOLL R SERIES Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2012-09-25
K121219 ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER Medtronic, Inc. DQY Class II 2012-09-25
K122259 BLOOD PRESSURE MONITOR WITH STETHOSCOPE Hangzhou Reli-On Co., Ltd. DXQ Class II 2012-09-24
K122089 OSTIAL PRO STENT POSITIONING SYSTEM Merit Medical Systems, Inc. DQX Class II 2012-09-21
K120462 AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) Inovise Medical, Inc. MLO Class II 2012-09-20
K120657 MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS Masimo Corporation DQA Class II 2012-09-19
K121917 PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM Penumbra, Inc. QEW Class II 2012-09-19
K120644 MERIT HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc. DQX Class II 2012-09-19
K122506 SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS Surefire Medical, Inc. DQX Class II 2012-09-17
K121694 IMAGER II ANGIOGRAPHIC CATHETER Boston Scientific Corp DQO Class II 2012-09-14
K100645 AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE Medtronic, Inc. DTZ Class II 2012-09-14
K121774 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS Boston Scientific Corp MCW Class II 2012-09-13
K121273 VISIONS PV .035 DITITAL IVUS CATHETER Volcano Corporation OBJ Class II 2012-09-10
K121372 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Andon Health Co, Ltd. DXN Class II 2012-09-10
K122612 HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX Maquet Cardiovascular, LLC MAL Class II 2012-09-10
K121885 EARLYSENSE CENTRAL DISPLAY SYSTEM Earlysense, Ltd. MSX Class II 2012-09-10
K122301 GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE Vascular Solutions Zerusa , Ltd. DTL Class II 2012-09-07
K121914 MASIMO SET USPO2 PULSE OXIMETRY CABLE Masimo Corporation DQA Class II 2012-09-07
K113821 TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM Transonic Systems, Inc. DXG Class II 2012-09-07
K112892 IMPELLA 2.5 PLUS CATHETER Abiomed, Inc. PBL 2012-09-06
K122628 SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES Datascope Corp., Cardiac Assist Division DSP Class II 2012-09-06

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