meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
49
Latest Decision
2014-02-14

Clearances · page 47 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133450 AIRSTRIP REMOTE PATIENT MONITORING Airstrip Technologies, LP MWI Class II 2014-02-14
K134004 VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE Cellco Partnership D/B/A Verizon Wireless DRG Class II 2014-02-14
K133296 XCATH Alseal DYB Class II 2014-02-14
K133629 ANGIOJET ULTRA AVX THROMBECTOMY SET Possis Medical, Inc. QEW Class II 2014-02-14
K130633 INTRODUCER SETS, MODEL ADELANTE RADIAL Oscor, Inc. DYB Class II 2014-02-13
K132720 HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH Merit Medical Systems, Inc. DYB Class II 2014-02-12
K140102 PHYSIOFLOW Q-LINK Vasocom, Inc. DSB Class II 2014-02-12
K133293 15 FR. TANDEMHEART ARTERIAL CANNULA Cardiacassist, Inc. DWF Class II 2014-02-12
K133274 VENA PRO Innovamed Health, LLC JOW Class II 2014-02-12
K122758 POWERHEART G5 AED Cardiac Science Corporation MKJ Class III 2014-02-12
K133607 V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc. OZT Class II 2014-02-11
K122632 GUAVA II Cardiocomm Solutions, Inc. DPS Class II 2014-02-11
K131146 ARTASSIST AND VENASSIST Aci Medical, LLC JOW Class II 2014-02-10
K130401 ALERTWATCH: OR Alertwatch, LLC MHX Class II 2014-02-07
K133552 MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT Hansen Medical DRA Class II 2014-02-07
K130921 ALIVECOR HEART MONITOR OTC AliveCor, Inc. DPS Class II 2014-02-06
K133396 VDRIVE WITH V-SONO Stereotaxis, Inc. DQX Class II 2014-02-06
K133701 NUVANT MCT SYSTEM Corventis, Inc. QYX Class II 2014-02-06
K133394 AIRSTRIP REMOTE PATIENT MONITORING Airstrip Technologies, LP MWI Class II 2014-02-06
K140036 APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH Aptus Endosystems, Inc. OTD Class II 2014-02-06
K140015 CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER Cardiosolutions, Inc. DYB Class II 2014-02-05
K130320 BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW Covidien DQA Class II 2014-02-04
K123475 SHOOCIN INTRODUCER KIT Lepu Medical Technology (Beijing) Co., Ltd. DYB Class II 2014-02-03
K133151 SARNS HIGH FLOW AORTIC ARCH CANNULA Terumo Cardiovascular Systems Corp. DWF Class II 2014-02-03
K140012 SORIN FLEXTHERM Sorin Group Deutschland GmbH DWC Class II 2014-01-31
K132807 MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) Welch Allyn, Inc. MWI Class II 2014-01-31
K131592 ENLIGHTN RENAL GUIDE CATHETER St. Jude Medical, Inc. DQY Class II 2014-01-31
K130872 CARDIOCEL Celxcel Pty, Ltd. DXZ Class II 2014-01-30
K133681 CRUX SNARE FILTER RETRIEVAL SET Volcano Corporation MMX Class II 2014-01-30
K132474 CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER Acist Medical Systems DXO Class II 2014-01-30
K132758 DIGITAL ELECTROCARDIOGRAPH Shenzhen Biocare Bio-Medical Equipment Co., Ltd. DPS Class II 2014-01-30
K131204 ADVANCE CS CORONARY SINUS INFUSION CATHETER Cook, Inc. DQY Class II 2014-01-29
K133236 TANDEMHEART FEMORAL VENOUS CANNULA SET Cardiacassist, Inc. DWF Class II 2014-01-29
K132163 MOORLDLS-BI LASER DOPPLER BURNS IMAGER Moor Instruments, Ltd. DPT Class II 2014-01-29
K132782 CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 Biosense Webster, Inc. DQK Class II 2014-01-24
K133622 MAC 2000 ECG ANALYSIS SYSTEM Wipro GE Healthcare DPS Class II 2014-01-23
K132928 MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE Medrad, Inc. / Bayer Medical Care, Inc. DXT Class II 2014-01-23
K133301 ZOE FLUID STATUS MONITOR Noninvasive Medical Technologies, Inc. DSB Class II 2014-01-22
K132682 PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA Atheromed, Inc. MCW Class II 2014-01-17
K133464 MODIFIED TREVO PROVUE RETRIEVER Concentric Medical, Inc. NRY Class II 2014-01-17
K131623 SMARTDOP XT Koven Technology, Inc. JOP Class II 2014-01-17
K131245 OREGON SCINTIFIC Idt Technology Limited DXN Class II 2014-01-17
K133379 HEM-7311 Omron Healthcare, Inc. DXN Class II 2014-01-16
K132528 E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES GE Healthcare Finland Oy DXG Class II 2014-01-16
K132641 MODIFIED TREVO PROVUE RETRIEVER Concentric Medical, Inc. NRY Class II 2014-01-13
K133261 MEDOS HILITE 7000 & 7000 LT OXYGENATOR Medos Medizintechnik AG DTZ Class II 2014-01-09
K131000 V-PATCH SYSTEM Intelesens Limited DSI Class II 2014-01-08
K130843 SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE Oscor, Inc. DRC Class II 2014-01-08
K131272 SIREN EPCR SUITE Medusa Medical Technologies, Inc. DXJ Class II 2014-01-03
K133026 UNBALLOON NON-OCCLUSION MODELING CATHETER LeMaitre Vascular, Inc. DQY Class II 2013-12-31
K131169 MOZEC - RX PTCA BALLOON DILATATION CATHETER Meril Life Sciences Private Limited LOX Class II 2013-12-24
K130325 ARM AUTOMATIC BLOOD PRESSURE MONITOR Shenzhen Pump Medical System Co., Ltd. DXN Class II 2013-12-24
K133569 TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM Bard Peripheral Vascular, Inc. OZT Class II 2013-12-20
K133626 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 MicroVention, Inc. KRD Class II 2013-12-20
K132652 VIA MICROCATHETER, VIA PLUS MICROCATHETER Sequent Medical, Inc. DQY Class II 2013-12-20
K133566 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS Boston Scientific Corp MCW Class II 2013-12-20
K130208 BERNOULLI ENTERPRISE SOFTWARE Cardiopulmonary Corp. MHX Class II 2013-12-20
K133587 PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 St. Jude Medical Systems AB DRG Class II 2013-12-20
K132026 V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 Mindray DS USA, Inc. MHX Class II 2013-12-20
K131765 ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM Conmed Corporation DSB Class II 2013-12-20
K132623 MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE Medtronic DQX Class II 2013-12-19
K133586 VISI MOBILE MONITIORING SYSTEM Sotera Wireless, Inc. MWI Class II 2013-12-18
K133243 OPTION ELITE VENA CAVA FILTER SYSTEM Rex Medical, L.P. DTK Class II 2013-12-17
K131919 ZOLL EPCR IOS ZOLL Medical Corporation DXJ Class II 2013-12-17
K132240 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES Grandway Technology (Shenzhen) Limited DXN Class II 2013-12-16
K132253 REMOVABLE PATIENT LEADS ECG CABLE Boston Scientific DSA Class II 2013-12-16
K133305 RHYTHM VIEW WORKSTATION Topera, Inc. DQK Class II 2013-12-16
K132803 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK Medapps Inc., Dba Alere Connect DRG Class II 2013-12-12
K130439 EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING Chongqing Psk Sci-Tech Development Co., Ltd. DRN Class II 2013-12-12
K133074 MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES Datascope Corp. DSP Class II 2013-12-12
K133230 INQWIRE DIAGNOSTIC GUIDE WIRE Merit Medical Systems, Inc. DQX Class II 2013-12-12
K123248 CPR RSQ ASSIST Avantech, Inc. LIX Class II 2013-12-10
K133029 ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE Compression Works, LLC DXC Class II 2013-12-06
K131550 HEART SYNC Heart Sync, Inc. MKJ Class III 2013-12-06
K133043 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE Angioslide, Ltd. LIT Class II 2013-12-06
K131497 MCKESSON CARDIOLOGY HEMO Mckesson Israel , Ltd. MWI Class II 2013-12-05
K132533 CARESCAPE MONITOR B450 GE Healthcare Finland Oy MHX Class II 2013-12-04
K132148 S HEALTH Samsung Electronics Co., Ltd. DRG Class II 2013-12-04
K132437 MARS HOLTER ANALYSIS WORKSTATION Ge Medical Systems Information Technologies, Inc. DQK Class II 2013-12-04
K132033 BM3/BM3 PLUS Noblitt & Rueland MWI Class II 2013-12-04
K132604 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM Covidien MWI Class II 2013-12-04
K131929 SURVEYOR CENTRAL STATION Mortara Instrument, Inc. MHX Class II 2013-12-03
K133282 REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM Reverse Medical Corporation KRD Class II 2013-11-27
K131913 INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC Philips Medizin Systeme Boeblingen GmbH DRG Class II 2013-11-26
K131998 ASPIRE RX-LP6 ASPIRATION CATHETER Control Medical Technology, LLC QEZ Class II 2013-11-26
K131699 EMOTION ECG MOBILE Mega Electronics , Ltd. DXH Class II 2013-11-26
K131897 CV3000 HOLTER ANALYSIS SYSTEM Vales & Hills Biomedical Tech. , Ltd. MLO Class II 2013-11-26
K130777 INBODY Biospace Corporation Limited MNW Class II 2013-11-25
K130856 BIA / VITALITY ANALYZER Ipgdx, LLC MNW Class II 2013-11-25
K132498 VALVED TEARAWAY INTRODUCER GENERATION II Medcomp (Medical Components, Inc.) DYB Class II 2013-11-25
K131482 SOFIA DISTAL ACCESS CATHETER MicroVention, Inc. DQY Class II 2013-11-22
K131819 PC ECG Edan Instruments, Inc. DPS Class II 2013-11-22
K132728 V8 TRANSLUMINAL BAV CATHETER Intervalve, Inc. OZT Class II 2013-11-22
K133399 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems Incorporated MCW Class II 2013-11-22
K130730 V-STICK VASCULAR ACCESS SET Argon Medical DYB Class II 2013-11-22
K131387 WRIGHT GRADIENT 52 - TORSO Wright Therapy Products, Inc. JOW Class II 2013-11-20
K132808 VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR Welch Allyn, Inc. MWI Class II 2013-11-20
K130707 ISIRONA MAGELLAN Isirona, LLC MSX Class II 2013-11-20
K123148 PARACE MD EKOSCOPE IS100 Parace, LLC DQD Class II 2013-11-19
K132712 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER Medtronic, Inc. KFM Class II 2013-11-19

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