meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
48
Latest Decision
2004-09-14

Clearances · page 85 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K041964 MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS Mediaid, Inc. DQA Class II 2004-09-14
K041442 EP-4 CLINICAL STIMUTATOR Ep Medsystems JOQ Class II 2004-09-14
K041528 MODIFICATION TO EPTFE GRAFT Vascutek, Ltd. DSY Class II 2004-09-14
K041867 HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N Hygia Health Services, Inc. NLF Class II 2004-09-10
K040178 PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE S.P.O. Medical Equipment, Ltd. DQA Class II 2004-09-10
K021096 X-SIZER CATHETER SYSTEM Ev3 Corporation MCW Class II 2004-09-08
K042128 MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) Zargis Medical Corp. DQD Class II 2004-09-08
K042190 MODEL 6416 TEMPORARY PACING LEAD SYSTEM Medtronic Vascular LDF Class II 2004-09-07
K041883 SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21 Leonhard Lang GmbH MKJ Class III 2004-09-07
K042088 SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 Heartsine Technologies, Inc. MKJ Class III 2004-09-02
K042187 ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 Micro Therapeutics, Inc. KRA Class II 2004-09-02
K041647 FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) Elekon Industries U.S.A., Inc. DQA Class II 2004-09-02
K041979 MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260 Quest Medical, Inc. DTR Class II 2004-09-02
K040831 DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 Datex-Ohmeda, Inc. DPZ Class II 2004-09-02
K040812 DETECT SURGICAL PACING AND MAPPING TOOL Medtronic Vascular LDF Class II 2004-09-02
K041705 RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 Omnisonics Medical Technologies QEY Class II 2004-09-01
K042265 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 Health & Life Co., Ltd. DXN Class II 2004-08-31
K042273 MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY Health Hero Network, Inc. DXN Class II 2004-08-31
K032831 PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 Conmed Corporation DQA Class II 2004-08-31
K040562 LIFECLINIC, MODEL 2400 Lifeclinic International, Inc. DXN Class II 2004-08-31
K041778 REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T Maxi-Aids, Inc. DXN Class II 2004-08-31
K041901 SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER North East Monitoring, Inc. MWJ Class II 2004-08-31
K042218 ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM Guidant Corp. NTE Class II 2004-08-31
K040380 DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 Dolphin Medical, Inc. DQA Class II 2004-08-31
K042177 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM Ge Medical Systems Information Technologies DPS Class II 2004-08-27
K041123 RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 Kerberos Proximal Solutions, Inc. DQO Class II 2004-08-26
K032971 TIDAL WAVE SP MODEL 710/715 AND 715 Respironics Novametrix, Inc. DQA Class II 2004-08-26
K033738 MONITORING SYSTEM, MODEL ARGUS PB-2200 Schiller AG DSK Class II 2004-08-24
K041169 PIESOMETER, MODEL MK-1 Canamet Canadian Natl Medical Technologies, Inc. DXN Class II 2004-08-24
K041400 FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 Fortifier International Co., Ltd. DXN Class II 2004-08-24
K042138 FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 Sein Electronics Co., Ltd. DXN Class II 2004-08-24
K042036 AIRGUARD VALVED INTRODUCER C.R. Bard, Inc. DYB Class II 2004-08-23
K032949 SPOT CHECK PULSE OXIMETER,512/513 Respironics Novametrix, Inc. DQA Class II 2004-08-23
K040799 HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS Hommed, LLC DXN Class II 2004-08-18
K040490 WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE Welch Allyn, Inc. DXN Class II 2004-08-18
K040922 VENTURE WIRE CONTROL CATHETER Velocimed, Inc. DQY Class II 2004-08-18
K041650 MICRO PRIME Innovx Medical, Inc. DWF Class II 2004-08-16
K041973 MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM Intra Luminal Therapeutics, Inc. DQX Class II 2004-08-16
K041993 2 CM PERIPHERAL CUTTING BALOON Boston Scientific Ivt PNO Class II 2004-08-16
K042022 E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER Datrix, Inc. Dba of Jon Barron, Inc. DXH Class II 2004-08-12
K033736 MERCI RETRIEVER, MODELS 90065, 90066 Concentric Medical, Inc. NRY Class II 2004-08-11
K040745 MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 Concentric Medical, Inc. DQY Class II 2004-08-11
K041697 TERUMO CIRCUIT CONNECTORS Terumo Cardiovascular Systems Corporation DTL Class II 2004-08-11
K040651 HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM Hommed, LLC DXN Class II 2004-08-10
K041434 C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS Analogic Corp. DSB Class II 2004-08-06
K041762 FINISHING WIRE SUPPORTRAK Guidant Corporation DQX Class II 2004-08-06
K032884 FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH Boston Scientific Epi NFA Class II 2004-08-06
K042014 DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 Sein Electronics Co., Ltd. DXN Class II 2004-08-06
K041689 POLYURETHANE BLOOD PRESSURE CUFFS D. E. Hokanson, Inc. DXQ Class II 2004-08-06
K041809 PERMANENT PACING LEAD, MODEL PY2 Oscor, Inc. DTB Class III 2004-08-06
K040637 POWERHEART AED G3 PRO Cardiac Science, Inc. MKJ Class III 2004-08-06
K041629 LYSUS INFUSION SYSTEM Ekos Corp. QEY Class II 2004-08-06
K041517 INFUSIONCATH Id, LLC QEY Class II 2004-08-05
K041531 ASAHI PTCA GUIDE WIRE CONFIANZA PRO Asahi Intecc Co., Ltd. DQX Class II 2004-08-03
K033685 NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 Medical Cv, Inc. KRH Class II 2004-08-03
K041815 LNCS OXIMETRY SENSORS Masimo Corp. DQA Class II 2004-07-29
K041644 FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) Elekon Industries U.S.A., Inc. DQA Class II 2004-07-29
K033463 EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE Edwards Lifesciences, LLC DWF Class II 2004-07-28
K041772 DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES Datex-Ohmeda MHX Class II 2004-07-28
K041790 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE Datex-Ohmeda MHX Class II 2004-07-23
K041907 TRIO MONITOR Datascope Corp. MWI Class II 2004-07-23
K041727 MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 Boston Scientific Scimed, Inc. OBJ Class II 2004-07-23
K041942 M2376A DEVICELINK SYSTEM Phillips Medical Systems MWI Class II 2004-07-23
K041716 PTFE FELTS AND PLEDGETS Boston Scientific Corp DXZ Class II 2004-07-22
K040978 TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE Tanita Corp. of America MNW Class II 2004-07-22
K041151 KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES Kerberos Proximal Solutions, Inc. DQY Class II 2004-07-22
K041453 SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 Smith & Nephew, Inc. DWQ Class II 2004-07-22
K041411 MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP Microlife Corp. DXN Class II 2004-07-21
K041741 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN Philips Medical Systems, Inc. MHX Class II 2004-07-21
K041376 C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A Analogic Corp. MWI Class II 2004-07-20
K040010 GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS Genesis Medical Interventional, Inc. QEW Class II 2004-07-19
K041338 MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES Medtronic Vascular MWS Class I 2004-07-19
K041674 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT Philips Medical Systems DQA Class II 2004-07-19
K041816 RTX3320PSTN WIRELESS TELEHEALTH GATEWAY Rtx Healthcare A/S DRG Class II 2004-07-19
K041607 QUINTON Q-TE; RMS Quinton Cardiology, Inc. MHX Class II 2004-07-16
K041624 PTCA STEERABLE HYDROPHILIC GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 2004-07-16
K041789 NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900T Meditec Co., Ltd. DXN Class II 2004-07-15
K040649 KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE Tyco Healthcare JOW Class II 2004-07-15
K033858 TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE European Custom Manufacturing BV LDF Class II 2004-07-12
K041574 CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 Guidant Corporation DTD Class II 2004-07-12
K041293 BIOPORE BALLOON DILATION CATHETER Bipore, Inc. LIT Class II 2004-07-09
K033488 CMI MAGNETOCARDIOGRAPH Cmi Cardiomag Imaging, Inc. DPS Class II 2004-07-07
K040498 MYSHELL Sedat S.A. DTL Class II 2004-07-02
K041558 STOCKERTIR PURGE CONTROL (APC) SYSTEM Stockert Instrumente GmbH DTW Class II 2004-07-02
K022823 VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 Geister Medizin Technik GmbH MGZ Class II 2004-07-01
K040155 PERIPHERAL CUTTING BALLOON Boston Scientific Corp PNO Class II 2004-07-01
K041459 LIFEPAK 12 DEFIBRILLATOR/MONITOR Medtronic Emergency Response Systems, Inc. MKJ Class III 2004-07-01
K032937 NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 Stereotaxis, Inc. DXX Class II 2004-07-01
K040438 POWERHEART AED G3A Cardiac Science, Inc. MKJ Class III 2004-07-01
K041686 BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM Arizant Healthcare, Inc. DWJ Class II 2004-06-30
K040663 TELENABLE EMS SYSTEM Molex, Inc. DRG Class II 2004-06-30
K034043 H-FLOW VALVE Elcam Medical Acal DQO Class II 2004-06-30
K041204 NC SP02 ADAPTER CABLE Masimo Corp. DQA Class II 2004-06-29
K041026 AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S Ambu, Inc. DRX Class II 2004-06-28
K041308 REMOTENURSE PATIENT MONITORING SYSTEM Webvmc, LLC DXH Class II 2004-06-28
K040511 SCD EXPRESS PORTABLE COMPRESSION SYSTEM Tyco Healthcare/Kendall JOW Class II 2004-06-28
K040911 VITALHEAT Dynatherm Medical, Inc. DWJ Class II 2004-06-22
K033464 EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE Edwards Lifesciences, LLC DWF Class II 2004-06-22
K040700 CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 Concentric Medical, Inc. DQY Class II 2004-06-21
K041313 STABIL-O-GRAPH I.E.M. GmbH DXN Class II 2004-06-18

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