meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
2005-03-25

Clearances · page 83 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050039 MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR Mars Medical Products DXN Class II 2005-03-25
K043454 CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 Medicomp, Inc. MLO Class II 2005-03-24
K043580 ALLIGATOR RETRIEVAL DEVICE (ARD) Chestnut Medical Technologies, Inc. DQY Class II 2005-03-24
K043393 REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS Alliance Medical Corp. NLH Class II 2005-03-23
K042040 TRIACTIV SYSTEM Kensey Nash Corp. NFA Class II 2005-03-23
K050139 MODIFICATION TO: EXPORT CATHETER Medtronic Vascular QEZ Class II 2005-03-22
K050584 GS-128 GRADIENT COMPRESSION SYSTEM Medmark Technologies, LLC JOW Class II 2005-03-22
K043361 ACCUHEART ELECTRODE BELT Advanced Bioelectric Corporation DRX Class II 2005-03-22
K050630 PIVOT STEERABLE MICROCATHETER Boston Scientific - Precision Vascular KRA Class II 2005-03-22
K050074 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 Welch Allyn, Inc. DPS Class II 2005-03-22
K042418 KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR Kodon(Tianjin)Electronic&Electrical Apparatus Co., DXN Class II 2005-03-21
K042999 CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 Biosense Webster, Inc. DQK Class II 2005-03-21
K050195 V-BAG WITH GBS COATING Gish Biomedical, Inc. DTN Class II 2005-03-17
K033436 REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER Alliance Medical Corp. OWQ Class II 2005-03-16
K043401 SPECTRANETICS LLD CS, MODEL 518-039 Spectranetics Corp. DRB Class II 2005-03-16
K050472 LYSUS INFUSION SYSTEM Ekos Corp. DRA Class II 2005-03-11
K042981 HYPERQ SYSTEM Biological Signal Processing, Ltd. MWI Class II 2005-03-10
K040751 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc. NLH Class II 2005-03-10
K042074 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc. NLH Class II 2005-03-09
K042109 DIASYS INTEGRA II Novacor France DXN Class II 2005-03-09
K050111 SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG Cobe Cardiovascular, Inc. DTN Class II 2005-03-08
K050447 PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR Dideco S.R.L. DTZ Class II 2005-03-08
K050276 DIVER C.E. CATHETER Invatec Innovative Technologies, S.R.L. QEZ Class II 2005-03-07
K050413 AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 Amplife Corporation DXN Class II 2005-03-04
K050175 SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 Spacelabs Medical, Inc. DSI Class II 2005-03-04
K050205 BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH Flowmedica, Inc. KRA Class II 2005-03-04
K043217 A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR A&D Engineering, Inc. DXN Class II 2005-03-03
K041374 AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 Idev Technologies, Inc. QEW Class II 2005-03-02
K042373 GALEO FOCUS GUIDE WIRE Biotronik, Inc. DQX Class II 2005-03-02
K043398 MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE Neometrics, Inc. DQX Class II 2005-03-01
K033646 TRIFIT 700 Healthfirst Corp. DRT Class II 2005-03-01
K043513 STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER Sterilmed, Inc. NLH Class II 2005-03-01
K043453 STERILEMED REPROCESSED IVUS IMAGING CATHETER Sterilmed, Inc. OWQ Class II 2005-03-01
K043457 MODIFICATION TO ENDOVASCULAR GUIDE WIRE Stereotaxis, Inc. DQX Class II 2005-02-28
K050004 PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 Philips Medical Systems MKJ Class III 2005-02-25
K043010 HOLTER RECORDER H3+ Mortara Instrument, Inc. MWJ Class II 2005-02-25
K050159 MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 3M Company DQD Class II 2005-02-22
K042768 MEDICOMPASS CONNECT Imetrikus, Inc. DXN Class II 2005-02-22
K043444 MULTIPLE, MODEL KTJ-50 Golden Horse Medical Equipment (Wuxi) Co. , Ltd. DXQ Class II 2005-02-22
K043572 COMPATIBILITY ECG TRUNK CABLES Datex-Ohmeda DSA Class II 2005-02-22
K043074 LIBERTY SYSTEM Inovise Medical, Inc. DPS Class II 2005-02-22
K050023 SECURELOC; ADVANCINTRODUCER Specialized Health Products, Inc. DYB Class II 2005-02-18
K043553 SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 Fox Hollow Technologies MCW Class II 2005-02-18
K042984 INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C Intervascular DWF Class II 2005-02-18
K043551 DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES Datex-Ohmeda MHX Class II 2005-02-18
K042904 INFINITY KAPPA XLT Draeger Medical Systems, Inc. MHX Class II 2005-02-18
K043439 INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL Draeger Medical Systems, Inc. MHX Class II 2005-02-18
K042308 SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 Facile Medical, Inc. DYB Class II 2005-02-17
K042553 BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER Biocardia, Inc. DQY Class II 2005-02-17
K043387 VASCON POLARIS GUIDING CATHETER Vascon, LLC DQY Class II 2005-02-16
K043370 PLANET 50 MONITORING SYSTEM Larsen & Toubro Limited MWI Class II 2005-02-15
K043438 LARGE BORE SPLITTABLE INTRODUCER KIT Thomas Medical Products, Inc. DYB Class II 2005-02-15
K043463 ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS Envitec-Wismar GmbH DQA Class II 2005-02-11
K050109 TRILLIUM BIOPUMP PLUS, MODEL BPX80T Medtronic Perfusion Systems KFM Class II 2005-02-11
K050073 MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L. DQY Class II 2005-02-11
K050141 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boeblingen GmbH MHX Class II 2005-02-11
K043525 CATHETER INTRODUCER Galt Medical Corp. DYB Class II 2005-02-09
K050068 LNOPV AD-L AND PD-L OXIMETRY SENSORS Masimo Corporation DQA Class II 2005-02-09
K043414 HL 188 & HL 189 BODY FAT METER Health & Life Co., Ltd. MNW Class II 2005-02-09
K042854 STEREOTAXIS ENDOVASCULAR GUIDE WIRE Stereotaxis, Inc. DQX Class II 2005-02-08
K043179 SELECT 3D ARTERIAL CANNULA Medtronic Perfusion Systems DWF Class II 2005-02-08
K050088 QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER Neoprobe Corp. DPW Class II 2005-02-08
K041892 ZOLL AED PRO EXTERNAL DEFIBRILLATOR ZOLL Medical Corporation MKJ Class III 2005-02-04
K050015 MODIFIED ACUMEN SHEATH, MODEL TTWO767 Acumen Medical, Inc. DYB Class II 2005-02-03
K043517 TRANSMITTER, ZS-940PA SERIES Nihon Kohden America, Inc. DRT Class II 2005-02-03
K050147 TRELLIS-8 PERIPHERAL INFUSION SYSTEM Bacchus Vascular, Inc. QEY Class II 2005-02-03
K043257 REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM Ep Technologies, Inc. DRF Class II 2005-02-03
K043371 BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER Biomerix Corporation KRD Class II 2005-02-03
K043323 D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR Dideco S.R.L. DTZ Class II 2005-02-01
K043423 MODEL SC-3008 SEQUENTIAL CIRCULATOR Bio Compression Systems, Inc. JOW Class II 2005-02-01
K043368 VITELCARE TURTLE, MODEL 400 Visual Telecommunications Network, Inc. MWI Class II 2005-02-01
K041630 ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS Cardiovascular Systems Incorporated MCW Class II 2005-01-31
K050049 DYNAFLO BYPASS GRAFT Bard Peripheral Vascular, Inc. DSY Class II 2005-01-31
K042937 MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER Vascular Solutions, Inc. QEZ Class II 2005-01-31
K043564 HORIZON ANGIO CATHLAB Mennen Medical , Ltd. DQK Class II 2005-01-27
K043550 AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 Amplife Corporation DXN Class II 2005-01-27
K042818 PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037 Matsushita Electric Works, Ltd. DXN Class II 2005-01-27
K042623 AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304 St. Jude Medical, Daig Division, Inc. DYB Class II 2005-01-27
K041031 CARDIOSTATION-100 (CS-100) Us Clover Co. DQK Class II 2005-01-26
K043065 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P Edwards Lifesciences, LLC DRS Class II 2005-01-26
K043534 MODIFICATION TO OUTBACK CATHETER Lumend, Inc. DQY Class II 2005-01-21
K043549 INFINITY GATEWAY SUITE, VF4 Draeger Medical Systems, Inc. MHX Class II 2005-01-21
K042536 MASIMO SET RAD 57 PULSE CO-OXIMETER Masimo Corporation DQA Class II 2005-01-19
K042628 MODIFICATION TO: RADIANALYZER, MODEL 12711 Radi Medical Systems AB DQK Class II 2005-01-19
K043060 OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 Omron Healthcare, Inc. MNW Class II 2005-01-19
K042108 VISTA PLUS Novacor MLO Class II 2005-01-19
K042849 CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) Cardiobiomedical Corporation DQK Class II 2005-01-13
K042254 PMP4 SELFCHECK ECG Card Guard Scientific Survival , Ltd. DXH Class II 2005-01-13
K043286 ANEROID SPHYGMOMANOMETER, MODEL BK2002 Wenzhou Bokang Instrument Co.,Ltd DXQ Class II 2005-01-13
K041736 PFA PATCH Peritec Biosciences, LLC DXZ Class II 2005-01-13
K043422 ASAHI PTCA GUIDE WIRE, J SHAPE SERIES Asahi Intecc Co., Ltd. DQX Class II 2005-01-12
K043437 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET Health & Life Co., Ltd. DXN Class II 2005-01-12
K042217 FLOWMEDIC, MODEL 220 Flowmedic (Israel), Ltd. JOW Class II 2005-01-12
K042528 INBODY, MODEL 3.0 Biospace Corporation Limited MNW Class II 2005-01-11
K042624 AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L. DQY Class II 2005-01-10
K043354 MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 Invivo Research, Inc. DRT Class II 2005-01-10
K042657 VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 Vioptix, Inc. MUD Class II 2005-01-10
K042117 PROXIS SYSTEM, MODEL EPS 101 Velocimed, Inc. DQY Class II 2005-01-07
K043359 4100 PATIENT OXIMETER MODULE Nonin Medical, Inc. DQA Class II 2005-01-07
K042814 READMYHEART Dailycare Biomedical, Inc. DPS Class II 2005-01-06

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