meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
45
Latest Decision
2010-01-29

Clearances · page 64 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K090427 URSA ANGIOGRAPHIC CATHETER Curative Medical Technology, Inc. DQO Class II 2010-01-29
K100014 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 Andon Health Co, Ltd. DXN Class II 2010-01-29
K093822 DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY Shepherd Scientific, Inc. DQX Class II 2010-01-28
K093681 MERIDIAN GUIDEWIRE Ev3 Neurovascular DQX Class II 2010-01-26
K092106 U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132 Taidoc Technology Corporation DXN Class II 2010-01-25
K094036 TURBO-TANDEM SYSTEM MODEL 472-110 Spectranetics Corp. MCW Class II 2010-01-25
K093986 AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS Sorin Group Italia S.R.L. DTM Class II 2010-01-22
K093823 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM Health & Life Co., Ltd. DXN Class II 2010-01-22
K093092 ODYSSEY WORKSTATION Stereotaxis, Inc. DQK Class II 2010-01-21
K093911 FOGARTY OCCLUSION CATHETER Edwards Lifesciences, LLC MJN Class II 2010-01-21
K093918 JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) Pathway Medical Technologies, Inc. MCW Class II 2010-01-21
K093022 THE PICC WAND PEELABLE SAFETY INTRODUCER Access Scientific, Inc. DYB Class II 2010-01-20
K093172 QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) Dynacardia, Inc. DPS Class II 2010-01-20
K093923 CEROX MODEL 3210 Or-Nim Medical , Ltd. MUD Class II 2010-01-19
K093657 ADAGIO RETRACTING ECG LEAD WIRES Acist Medical Systems, Inc. DSA Class II 2010-01-15
K093970 PICA CATHETER Penumbra, Inc. LIT Class II 2010-01-15
K093882 SORIN C5 SYSTEM MODEL 58-00-00 Sorin Group Deutschland GmbH DTQ Class II 2010-01-15
K093658 RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS Renu Medical, Inc. JOW Class II 2010-01-14
K093730 PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) Edwards Lifesciences, LLC DWF Class II 2010-01-14
K092158 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS Sterilmed, Inc. NLH Class II 2010-01-14
K093231 ALBOGRAFT VASCULAR PROSTHESIS LeMaitre Vascular, Inc. MAL Class II 2010-01-14
K093659 ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 C.R. Bard, Inc. DTK Class II 2010-01-14
K092893 TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES Tytan Medical Corp. DXN Class II 2010-01-14
K093832 LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES Levitronix, LLC DWA Class II 2010-01-13
K093866 EVALVE STEERABLE GUIDE CATHETER Evalve, Inc. DRA Class II 2010-01-13
K092811 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 Andon Health Co, Ltd. DXN Class II 2010-01-13
K092118 ANGIOGRAPHIC CATHETER, MODEL ANGIOS Oscor, Inc. DQO Class II 2010-01-13
K093925 LIFENET SYSTEM Physio-Control, Inc. MSX Class II 2010-01-12
K092652 FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2010-01-08
K093013 BLOOD PRESSURE MONITOR, MODEL MD200A Beijing Choice Electronic Technololgy Co., Ltd. DXN Class II 2010-01-08
K091954 MICRO-STICK SET Medcomp DYB Class II 2010-01-08
K093817 GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS Vascutek, Ltd. DSY Class II 2010-01-07
K090637 CARDIO-WRAP Mast Biosurgery USA, Inc. DXZ Class II 2010-01-07
K083384 THERMODILUTION CATHETER Biosensors Intl. Pte. , Ltd. DQO Class II 2010-01-05
K093111 MIKRO-CATH, MODEL 825-0101 Millar Instruments, Inc. DXO Class II 2010-01-05
K092174 ENABLER-P CATHETER SYSTEM, MODEL 3000 Endocross, Ltd. DQY Class II 2009-12-30
K093139 BANTAM,48XXXXXX, 50XXXXXX ClearStream Technologies , Ltd. LIT Class II 2009-12-30
K092588 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 Andon Health Co, Ltd. DXN Class II 2009-12-29
K093141 MARS HOLTER ANALYSIS WORKSTATION Ge Medical Systems Information Technologies DQK Class II 2009-12-29
K093551 PARADIS VASO SHIELD Spinemedica, LLC OMR Class II 2009-12-24
K091265 ZOLL E SERIES WITH CPRREADYCHARGE Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2009-12-23
K093452 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 Andon Health Co, Ltd. DXN Class II 2009-12-23
K090534 VENOUS HARDSHELL CARDIOTOMY RESERVIORS Maquet Cardiopulmonary, AG DTN Class II 2009-12-23
K090555 PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 Maquet Cardiopulmonary, AG DTR Class II 2009-12-23
K092510 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 Andon Health Co, Ltd. DXN Class II 2009-12-23
K093720 STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO Boston Scientific Corp LIT Class II 2009-12-23
K090690 VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING Maquet Cardiopulmonary, AG DTN Class II 2009-12-23
K093636 STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX Boston Scientific Corp LIT Class II 2009-12-23
K090518 QUART ARTERIAL FILTER WITH SOFTLINE COATING Maquet Cardiopulmonary, AG DTM Class II 2009-12-18
K093050 ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 Arrow Intl., Inc. DQY Class II 2009-12-18
K093601 AF 840 PH.I.S.I.O. ARTERIAL FILTER Sorin Group Italia S.R.L. DTM Class II 2009-12-18
K090515 ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) Maquet Cardiopulmonary, AG KFM Class II 2009-12-18
K090533 HLM TUBING SET WITH SOFTLINE COATING Maquet Cardiopulmonary, AG DWF Class II 2009-12-18
K093177 INTELLIBRIDGE SYSTEM Philips Medical Systems MWI Class II 2009-12-18
K083174 HEALTHEPOD Card Guard Scientific Survival , Ltd. DXH Class II 2009-12-17
K093397 TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE MicroVention, Inc. DQX Class II 2009-12-17
K090785 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 Invivo Corp. MWI Class II 2009-12-15
K093583 EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE St Jude Medical DQK Class II 2009-12-15
K092663 ELI 350 ELECTROCARDIOGRAPH Mortara Instrument, Inc. DPS Class II 2009-12-14
K092807 HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 Augustine Biomedical & Design, LLC DWJ Class II 2009-12-10
K092744 NEONATAL ECG ELECTRODE, M203KEN R & D Medical Products, Inc. DRX Class II 2009-12-10
K092644 TERUMO PRESSURE ISOLATOR Terumo Cardiovascular Systems Corp. DRS Class II 2009-12-10
K092596 EAGLE EYE PLATINUM DIGITAL IVUS CATHETER Volcano Corporation OBJ Class II 2009-12-10
K093750 ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA Ev3, Inc. KRA Class II 2009-12-09
K093052 CROSSCATH SUPPORT CATHTER Cook, Inc. KRA Class II 2009-12-08
K093522 QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C Maquet Cardiopulmonary, AG DTZ Class II 2009-12-07
K091582 GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 Medtronic Vascular DQX Class II 2009-12-04
K093455 CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES Biosense Webster, Inc. DQK Class II 2009-12-04
K092620 MD300C318 FINGERTIP PULSE OXIMETER Beijing Choice Electronic Technololgy Co., Ltd. DQA Class II 2009-12-04
K091352 SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 Biosense Webster, Inc. OBJ Class II 2009-12-04
K092514 UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES Hangzhou Hua'An Medical & Health Instruments Co., DXN Class II 2009-12-04
K093528 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 Andon Health Co, Ltd. DXN Class II 2009-12-04
K092598 ZOLL E SERIES WITH SPCO/SPMET OPTION Zoll Medical Corporation, World Wide Headquarters MKJ Class III 2009-12-03
K092727 H100B PULSE OXIMETER Edan Instruments, Inc. DQA Class II 2009-12-03
K093456 JETSTREAM G3 SYSTEM Pathway Medical Technologies, Inc. MCW Class II 2009-12-01
K093134 CERNER CAREAWARE IBUS Cerner Corp. DRG Class II 2009-11-27
K093359 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 Shanghai Little Doctor Co. Limited DXN Class II 2009-11-27
K093387 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 Andon Health Co, Ltd. DXN Class II 2009-11-27
K092999 NBP CUFF Draeger Medical AG & Co. KG DXQ Class II 2009-11-24
K093501 ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION Spacelabs Medical, Inc. MHX Class II 2009-11-24
K092702 MICRUS MICROCATHETER, MODEL COURIER 270 Micrus Endovascular Corporation DQO Class II 2009-11-20
K092153 SKYLINE 55, MODEL VER 1 Larsen & Toubro Limited MWI Class II 2009-11-20
K093303 SCOUTPRO 7F LONG CATHETERS Biotronik, Inc. DQY Class II 2009-11-20
K092503 RADAR VASCULAR COMPRESSION DEVICES Advanced Vascular Dynamics DXC Class II 2009-11-19
K093389 CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK Computerized Screening, Inc. DXN Class II 2009-11-17
K092163 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB Health & Life Co., Ltd. DXN Class II 2009-11-16
K092549 OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P Bio Medical Technologies Co., Ltd. DQA Class II 2009-11-16
K091176 PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 Philips Medical Systems MSX Class II 2009-11-13
K093286 POWERCROSS .018 OTW PTA DILATION CATHETER Ev3, Inc. LIT Class II 2009-11-13
K091241 MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER Masimo Corporation DQA Class II 2009-11-06
K093184 ENVOY GUIDING CATHETERS Codman & Shurtleff, Inc. DQY Class II 2009-11-06
K093307 ASEPT PLEURAL DRAINAGE SYSTEM Pfm Medical, Inc. DWM Class II 2009-11-06
K093301 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM Ev3, Inc. MCW Class II 2009-11-06
K091367 GDS-DCS Guided Delivery Systems DYB Class II 2009-11-05
K092298 MODIFICATION TO MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. DQY Class II 2009-11-05
K093160 HEADWAY 21 MICROCATHETER, MODEL: MC212150S MicroVention, Inc. DQY Class II 2009-11-05
K092463 SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH DTQ Class II 2009-11-05
K092563 GATOR CLIPSEAL PLUG Vascular Solutions, Inc. DTL Class II 2009-11-04
K093130 ENGAGE TR INTRODUCER St Jude Medical DYB Class II 2009-11-04
K091750 GUIDELINER CATHETER, MODELS 5571, 5572, 5573 Vascular Solutions, Inc. DQY Class II 2009-11-04

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