meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
2005-01-06

Clearances · page 84 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K043348 MODIFICATION TO PM-8000 PATIENT MONITOR Shenzhen Mindray Bio-Medical Electronics Co., Ltd. MWI Class II 2005-01-06
K042316 VANGUARD REPROCESSED PULSE OXIMETER SENSORS Vanguard Medical Concepts, Inc. NLF Class II 2005-01-06
K042827 CARDIOFAX CE, MODEL PEA-1110K Nihon Kohden America, Inc. DPS Class II 2005-01-06
K043552 VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES Vascutek, Ltd. DSY Class II 2005-01-05
K043162 PMP4 OXY PRO Card Guard Scientific Survival , Ltd. DQA Class II 2004-12-29
K042705 DISPOSABLE NON-ADHESIVE SPO2 SENSORS Elekon Industries U.S.A., Inc. DQA Class II 2004-12-29
K042381 CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 Acumen Medical, Inc. DQY Class II 2004-12-28
K040778 TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) Tanita Corp. of America MNW Class II 2004-12-23
K043276 DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE Datex-Ohmeda MHX Class II 2004-12-23
K043269 Lysus Infusion System Ekos Corp. QEY Class II 2004-12-22
K033559 12-LEAD GLOVE Ineedmd DRX Class II 2004-12-22
K042370 TORAYGUIDE GUIDEWIRE Toray Industries (America), Inc. DQX Class II 2004-12-17
K042399 MODIFICATION TO SHORT INTRODUCER SHEATH Rex Medical, L.P. DYB Class II 2004-12-17
K042734 SJM RIGID SADDLE RING MODEL RSAR-(SIZE) St. Jude Medical, Inc. KRH Class II 2004-12-17
K040592 CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE Cordis Corp. DQX Class II 2004-12-17
K033266 VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS Medical Imaging Applications, LLC DQK Class II 2004-12-16
K042489 6F Z4 GUIDE CATHETER Medtronic Vascular DQY Class II 2004-12-13
K033973 OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR Nellcor Puritan Bennett, Inc. NLF Class II 2004-12-13
K032825 VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR Mars Medical Products Co., Ltd. DXN Class II 2004-12-10
K042784 MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM Medrad, Inc. DXT Class II 2004-12-10
K042413 ACS MODEL NCP-2 Applied Cardiac Systems DRN Class II 2004-12-09
K043103 VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 Edwards Lifesciences, LLC DXG Class II 2004-12-09
K041294 BIOZDX HEMODYNAMIC MONITOR Cardiodynamics International Corp. DSB Class II 2004-12-08
K043186 H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM Health & Life Co., Ltd. DXN Class II 2004-12-06
K042675 FLEXI-STAT SP02 EAR SENSOR Elekon Industries U.S.A., Inc. DPZ Class II 2004-12-06
K042148 HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES Ge Medical Syst. Information Technologies DQK Class II 2004-12-03
K042967 A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 A&D Engineering, Inc. DXN Class II 2004-12-03
K043023 PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 LeMaitre Vascular, Inc. MJN Class II 2004-12-03
K041693 WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES Hangzhou Hua'An Medical & Health Instruments Co., DXN Class II 2004-12-02
K041708 ENPATH SAFETY INTRODUCER Enpath Medical Incorporated DYB Class II 2004-11-30
K042744 OPTIV ANTAGE DH POWER INJECTION SYSTEM Mallinckrodt Inc., Liebel-Flarsheim Business DXT Class II 2004-11-30
K042704 REUSABLE FINGER CLIP SPO2 SENSORS Elekon Industries U.S.A., Inc. DQA Class II 2004-11-26
K042264 GUIDEWIRES Rocket Medical Plc DQX Class II 2004-11-24
K043096 COMMANDER II Cardiocom DXN Class II 2004-11-24
K042996 COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE Volcano Therapeutics, Inc. DQX Class II 2004-11-24
K042910 VENTURE WIRE CONTROL CATHETER, MODEL WCC Velocimed, Inc. DQY Class II 2004-11-22
K042685 METRICATH SYSTEM Angiometrx, Inc. DQO Class II 2004-11-18
K042845 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS Philips Medizin Systeme Boblingen GmbH MSX Class II 2004-11-12
K042908 RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM Guidant Corp. NTE Class II 2004-11-12
K042611 LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE Cook, Inc. DQX Class II 2004-11-12
K042144 NICOM Cheetah Medical, Inc. DXG Class II 2004-11-12
K043018 OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 Omron Healthcare, Inc. DXN Class II 2004-11-10
K042853 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA Health & Life Co., Ltd. DXN Class II 2004-11-10
K042538 SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX Invatec Innovative Technologies DQY Class II 2004-11-08
K042537 SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX Invatec Innovative Technologies DQY Class II 2004-11-08
K042230 POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM Cryo Vascular Systems, Inc. DQY Class II 2004-11-05
K040684 T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 Spectros Corporation MUD Class II 2004-11-05
K042874 ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX) Possis Medical, Inc. QEZ Class II 2004-11-05
K042775 INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER Irvine Biomedical, Inc. DRF Class II 2004-11-04
K042642 AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) Ge Medical Systems Information Technologies MHX Class II 2004-11-03
K041659 C-BOOT C-Boot , Ltd. JOW Class II 2004-10-28
K042388 RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE Radiant Medical DQY Class II 2004-10-28
K042376 ACUMEN SHEATH, MODEL TTW7807 Acumen Medical, Inc. DYB Class II 2004-10-26
K042302 ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE Zoll Medical Corp LDD Class II 2004-10-26
K042802 H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q Health & Life Co., Ltd. DXN Class II 2004-10-26
K041486 VASOSTASIS VASCULAR CLOSURE SYSTEM Cardiva Medical, Inc. DXC Class II 2004-10-22
K042799 QRS-CARD CARDIOLOGY SUITE Pulse Biomedical, Inc. DQK Class II 2004-10-22
K042002 SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER Ela Medical, Inc. DQK Class II 2004-10-20
K042708 ERA 3000 PACING SYSTEM ANALYZER Biotronik, Inc. DTE Class II 2004-10-20
K041506 INTRAVASCULAR ACCESS INTRODUCER SHEATH Applied Medical Resources Corp. DYB Class II 2004-10-15
K042306 PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A Philips Medizin Systeme Boeblingen GmbH DQA Class II 2004-10-15
K041740 SILICONE COATED GUIDEWIRE Arrow International, Inc. DQX Class II 2004-10-15
K041918 INTEGRATED PATIENT MONITORING SYSTEM Invivo Research, Inc. MWI Class II 2004-10-15
K042493 ENSITE SYSTEM, MODEL EE3000 Endocardial Solutions, Inc. DQK Class II 2004-10-15
K042568 EXCELSIOR 1018 AND SL-10 MICROCATHETERS Boston Scientific Corp DQY Class II 2004-10-15
K041934 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 3M Company DQD Class II 2004-10-15
K042771 GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 Datex-Ohmeda MSX Class II 2004-10-15
K042593 ACUSON ACUNAV 8F ULTRASOUND CATHETER Siemens Medical Solutions USA, Inc. OBJ Class II 2004-10-15
K042581 AMLUCK, YA HORNG Ya Horng Electronic Co., Ltd. DXN Class II 2004-10-13
K042501 ETG-4000 OPTICAL TOPOGRAPHY SYSTEM Hitachi Medical Corp. DQA Class II 2004-10-12
K042616 BIOMEDIX PADNET LAB Biomedix, Inc. JOM Class II 2004-10-12
K031728 KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET Klimamed Technologie Medizingerate GmbH DWJ Class II 2004-10-12
K042541 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Cryo Vascular Systems, Inc. DQY Class II 2004-10-12
K042560 STELLAR 404 MONITORING SYSTEM Larsen & Toubro Limited MWI Class II 2004-10-06
K041854 MPM SYSTEM Aerotel Medical Systems, Ltd. DXN Class II 2004-10-06
K042656 INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 Draeger Medical Systems, Inc. MHX Class II 2004-10-06
K042156 CARDEON COBRA CATHETER Cardeon Corp. DWF Class II 2004-10-06
K042469 BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER Braemar, Inc. MWJ Class II 2004-10-06
K042060 EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE Millimed A/S DTL Class II 2004-10-06
K042417 ZOLL M SERIES ETC02 LOFLO OPTION Zoll Medical Corp MKJ Class III 2004-10-05
K042569 8600 VITAL SIGNS MONITOR Criticare Systems, Inc. MWI Class II 2004-09-29
K042105 CLIPPER DIAGNOSTIC ELECTRODE CATHETER Bard Electrophysiology DRF Class II 2004-09-23
K042374 STOCKERT SCP RHYTHM Stockert Instrumente GmbH DWA Class II 2004-09-23
K041909 VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) Vascular Solutions, Inc. DQO Class II 2004-09-23
K042456 Lysus Infusion System Ekos Corp. QEY Class II 2004-09-23
K041127 MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS Sterilmed, Inc. NLF Class II 2004-09-23
K042463 HOLTER PLUS Rozinn Electronics, Inc. DQK Class II 2004-09-22
K041734 AMBU DISPOSABLE ECG ELECTRODE Ambu, Inc. DRX Class II 2004-09-22
K040915 MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M Invivo Research, Inc. MWI Class II 2004-09-22
K041491 ZEWA MFM-007 BLOOD PRESSURE MONITOR Zewa, Inc. DXN Class II 2004-09-20
K042346 LNCS OXIMETRY SENSORS Masimo Corporation DQA Class II 2004-09-20
K042338 CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 2004-09-16
K040904 PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A Philips Medical Systems NSA Class III 2004-09-16
K040942 VST3 Biowatch Medical, Inc. DXH Class II 2004-09-15
K042020 SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) Hutchinson Technology, Inc. MUD Class II 2004-09-15
K042194 ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY Medtronic Vascular DQY Class II 2004-09-15
K041954 DISPOSABLE MONITORING ELECTRODES Shanghai Intco Electrode Manufacturing Co., Ltd. DRX Class II 2004-09-15
K040479 PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 Welch Allyn, Inc. MKJ Class III 2004-09-14
K041522 FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS Elekon Industries U.S.A., Inc. DQA Class II 2004-09-14
K042113 ZOE FLUID STATUS MONITOR Noninvasive Medical Technologies, LLC DSB Class II 2004-09-14

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