meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
2013-06-06

Clearances · page 50 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K131329 VECTOR PTA BALLOON DILATATION CATHETER R4 Vascular, Inc. LIT Class II 2013-06-06
K131346 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR Microlife Intellectual Property GmbH DXN Class II 2013-06-06
K131103 XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR Sorin Group Italia S.R.L. DTN Class II 2013-06-06
K130773 TEMPUS PRO PATIENT MONITOR Remote Diagnostic Technologies , Ltd. MWI Class II 2013-06-05
K130382 HEARTSTRING III PROXIMAL SEAL SYSTEM Boston Scientific Corporation DXC Class II 2013-06-05
K122365 ULTRACHECK CURVE BLOOD PRESSURE CUFFS Statcorp Medical OED Class II 2013-06-04
K130290 MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE Intel-Ge Care Innovations, LLC DRG Class II 2013-06-04
K124046 VALVED TEARAWAY INTRODUCER GENERATION II Medical Components, Inc. DYB Class II 2013-06-03
K130293 ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER Cook, Inc. LIT Class II 2013-05-31
K130338 IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS ImpediMed Limited OBH Class II 2013-05-31
K131199 ULTRAVERSE RX PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. LIT Class II 2013-05-30
K130311 TRANSTEK BODY FAT ANALYZER Guangdong Transtek Medical Electronics Co., Ltd. MNW Class II 2013-05-30
K131225 ADROIT GUIDING CATHETER Cordis Corp., A Johnson & Johnson Co. DQY Class II 2013-05-29
K131121 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR Health & Life Co., Ltd. DXN Class II 2013-05-29
K130411 740 SELECT Cas Medical Systems, Inc. MWI Class II 2013-05-29
K130288 STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE Cardiac Insight, Inc. DSH Class II 2013-05-29
K131045 ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE Cardiac Designs, LLC DQK Class II 2013-05-29
K123041 VASOSTAT HEMOSTASIS DEVICE Forge Medical, Inc. DXC Class II 2013-05-29
K123801 FINGER PULSE OXIMETER Shenzhen Kingyield Technology Co., Ltd. DQA Class II 2013-05-28
K130911 RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER Ev3, Inc. LIT Class II 2013-05-24
K130559 MOBICATH BI-DIRECTIONAL GUIDING SHEATH Great Batch Medical DYB Class II 2013-05-24
K130639 ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER Maquet Cardiopulmonary, AG DWF Class II 2013-05-16
K130366 BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT C.R. Bard, Inc. DTK Class II 2013-05-15
K123800 WRIST AUTOMATIC BLOOD PRESSURE MONITOR Little Doctor Electronic (Nantong)Co.,Ltd DXN Class II 2013-05-15
K123077 VASCULAR CLAMPS Hebumedical GmbH DXC Class II 2013-05-14
K123551 ITCLAMP 50 Innovative Trauma Care, Inc. DXC Class II 2013-05-14
K122013 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) Microlife Corp. DXN Class II 2013-05-13
K123871 FINGERTIP PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2013-05-10
K130796 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM Covidien MWI Class II 2013-05-09
K123581 NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN Covidien, Formerly Nellcor Puritan Bennett, Inc. DQA Class II 2013-05-09
K123095 MEDLINE BLOOD PRESSURE TRANSDUCER Medline Industries, Inc. DRS Class II 2013-05-08
K123600 DIGITAL BLOOD PRESSURE MONITOR Little Doctor Electronic (Nantong)Co.,Ltd DXN Class II 2013-05-03
K121404 SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM Onset Medical Corporation DYB Class II 2013-05-03
K130594 ENSITE VELOCITY SYSTEM St Jude Medical DQK Class II 2013-05-03
K130786 SLEEK OTW PTA CATHETER C.R. Bard, Inc. LIT Class II 2013-05-03
K130174 DVTCARE CA5 Ossur Americas, Inc. JOW Class II 2013-05-02
K122388 SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514 Seca GmbH & Co. KG MNW Class II 2013-05-02
K130626 MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS Ge Medical Systems Information Technologies, Inc. DQK Class II 2013-05-01
K130957 WVSM (WIRLESS VITAL SIGNS MONITOR) Athena Gtx MWI Class II 2013-04-30
K123482 REFLOW ASPIRATION CATHETER Volcano Corporation QEZ Class II 2013-04-29
K130482 COMBAT READY CLAMP Combat Medical Systems, LLC DXC Class II 2013-04-29
K123921 BODYTRONIC 200 Bauerfeind AG JOM Class II 2013-04-26
K123990 SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING Medtronic Vascular DYB Class II 2013-04-26
K120984 MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR Masimo Corporation DQA Class II 2013-04-26
K130896 VASCULAR PROBE, VASCULAR PROBE ES Synovis Life Technologies, Inc. DWP Class II 2013-04-24
K122826 PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM; PREVIEW CATHETER MODEL 87000; PIMF MODEL 87-PIMF; LAPTOP SYSTEM Volcano Corporation DQY Class II 2013-04-24
K123295 RHYTHM VIEW Topera, Inc. DQK Class II 2013-04-24
K123658 BIOMODULE 3-M1 Zephyr Technology Corporation DRX Class II 2013-04-24
K130161 PASSEO-35 Biotronik, Inc. LIT Class II 2013-04-23
K122381 NEXFIN MODEL 2 Edwards Lifesciences, LLC DXN Class II 2013-04-22
K123539 STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK Stayhealthy, Inc. DXN Class II 2013-04-22
K122146 XHIBIT CENTRAL STATION, MODEL 96102 Spacelabs Healthcare MHX Class II 2013-04-22
K122167 NEXXIS OR Barco N.V. DXJ Class II 2013-04-22
K124049 DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM Spectralmd, Inc. DPT Class II 2013-04-18
K122461 RHYTHMIA MAPPING CATHETER Rhythmia Medical, Inc. DRF Class II 2013-04-18
K123900 SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 Philips Medical Systems MHX Class II 2013-04-18
K123083 COVIDIEN WARMTOUCH CONVECTIVE WARMING UNIT Covidien DWJ Class II 2013-04-17
K123597 TRUECPR COACHING DEVICE Physio-Control, Inc. LIX Class II 2013-04-17
K122076 PERSONAL HEALTH CENTER (PHC) Adflow Health Networks, Inc. DXN Class II 2013-04-15
K123621 OPTICROSS 40 MHZ CORONARY IMAGING CATHETER Boston Scientific Corp OBJ Class II 2013-04-15
K123430 MICROSLIDER TEARAWAY INTRODUCER SET Galt Medical Corp. DYB Class II 2013-04-12
K130677 APTUS HELI-FX AORTIC SECUREMENT SYSTEM Aptus Endosystems, Inc. OTD Class II 2013-04-12
K123700 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER Cas Medical Systems, Inc. MUD Class II 2013-04-11
K130056 PATIENT MONITOR Ld Technology, LLC MWI Class II 2013-04-11
K130711 INFINITY CENTRALSTATION WITH INFINITY M300 Draeger Medical Systems, Inc. MHX Class II 2013-04-11
K122996 ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 Xhale DQA Class II 2013-04-10
K130637 JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM Medrad, Inc. MCW Class II 2013-04-10
K130215 GORE ACUSEAL VASCULAR GRAFT W. L. Gore & Associates, Inc. DSY Class II 2013-04-09
K123153 ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT Medtronic, Ireland DQY Class II 2013-04-09
K130571 DEVON CIRONA 6100 DVT Devon Medical, Inc. JOW Class II 2013-04-09
K123996 RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF Ge Medical Systems Information Technologies, Inc. DXQ Class II 2013-04-09
K123916 PSA SERIES Osypka Medical, Inc. DTE Class II 2013-04-09
K130588 MERIT HYDROPHILIC GUIDE WIRE Merit Medical Systems, Inc. DQX Class II 2013-04-05
K123445 NMI COAXIAL MICROINTRODUCER SET Navilyst Medical, Inc. DRE Class II 2013-04-01
K123984 QUANTIEN MEASUREMENT SYSTEM Radi Medical Systems AB DQK Class II 2013-03-28
K122272 CARDIOMEM Getemed Medizin- Und Informationstechnik AG MWJ Class II 2013-03-28
K123762 DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF Medtronic, Inc. DWF Class II 2013-03-27
K123618 AXERA 2 ACCESS SYSTEM Arstasis, Inc. DYB Class II 2013-03-24
K123556 MORTARA SURVEYOR PATIENT MONITOR Mortara Instrument, Inc. MHX Class II 2013-03-22
K123303 FEMORAL ACCESS VENOUS CANNULAE Edwards Lifesciences, LLC DWF Class II 2013-03-22
K122253 PROCARE MONITOR B20 Ge Medical Systems China Co., Ltd. MHX Class II 2013-03-22
K123498 BP652N (HEM-6300-Z) Omron Healthcare, Inc. DXN Class II 2013-03-21
K122098 APPS-HEALTH01 Andon Health Co, Ltd. DXN Class II 2013-03-21
K113727 SHENZHEN MED-LINK PULSE OXIMETER PROBE Shenzhen Med-Link Electronics Tech Co., Ltd. DQA Class II 2013-03-21
K130257 CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER St Jude Medical DQY Class II 2013-03-20
K130433 INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE Sorin Group Italia S.R.L. DTZ Class II 2013-03-20
K122247 LIDCORAPID V2 MONITOR Lidco, Ltd. DXG Class II 2013-03-20
K130252 CPS AIM UNIVERSAL SLITTABLE INNER CATHETER St Jude Medical DQY Class II 2013-03-20
K123765 GUIDEZILLA GUIDE EXTENSION CATHETER Boston Scientific DQY Class II 2013-03-19
K122940 ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 Cook, Inc. DQY Class II 2013-03-19
K123351 AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE Medtronic Perfusion Systems DTM Class II 2013-03-19
K123477 VIA MICROCATHETER, VIA PLUS MICROCATHETER Sequent Medical, Inc. KRA Class II 2013-03-19
K123108 TVC IMAGING SYSTEM MODEL NIRS-MC7-70 Infraredx, Inc. OGZ Class II 2013-03-15
K123298 FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING Edwards Lifesciences, LLC DWF Class II 2013-03-15
K130142 FLIXENE IFG VASCULAR GRAFT Atrium Medical Corporation DSY Class II 2013-03-15
K130124 CATALYST II AND III Cardiva Medical, Inc. DXC Class II 2013-03-14
K130280 CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR Terumo Corporation DTZ Class II 2013-03-13
K123370 EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA Edwards Lifesciences, LLC DWF Class II 2013-03-13
K130493 CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR Terumo Corporation DTZ Class II 2013-03-13
K130234 NUVON VITALS CHARTING SYSTEM Nuvon, Inc. MWI Class II 2013-03-13

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