meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
50
Latest Decision
2003-01-15

Clearances · page 92 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K024365 TM2005 PERSONAL MEDICAL PHONE CENTER Card Guard Scientific Survival , Ltd. DXH Class II 2003-01-15
K022145 OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 LeMaitre Vascular, Inc. DXE Class II 2003-01-14
K024126 CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT Abbott Laboratories DQO Class II 2003-01-14
K024156 PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR Oscor, Inc. DTD Class II 2003-01-14
K023834 HL888 Health & Life Co., Ltd. DXN Class II 2003-01-14
K022078 SOLA, COUNTER-PULSATION, MODEL SECP-S Sola Medical Devices, LLC DRN Class II 2003-01-10
K023183 MEDRAD STELLANT CT INJECTOR SYSTEM Medrad, Inc. DXT Class II 2003-01-10
K022909 NIKOMED TRACE 1 ECG ELECTRODES Nikomed U.S.A., Inc. DRX Class II 2003-01-09
K020784 JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS Jostra AG DWF Class II 2003-01-09
K020863 CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM Biosense Webster, Inc. DQK Class II 2003-01-09
K023960 LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 Lidco, Ltd. DXG Class II 2003-01-09
K024069 ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 Medtronic Vascular DWF Class II 2003-01-08
K021694 CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 Cardiovention, Inc. DTQ Class II 2003-01-08
K022272 MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) Medtronic Cardiac Surgical Products DWF Class II 2003-01-08
K023427 CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 Cardiomedics, Inc. DRN Class II 2003-01-07
K023334 BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 Baylis Medical Co., Inc. DSA Class II 2002-12-31
K024035 ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY Medtronic Vascular DQY Class II 2002-12-30
K024058 MODIFICATION TO CARDEON AEGIS CATHETER Cardeon Corp. DWF Class II 2002-12-30
K024032 ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY Medtronic Vascular DQY Class II 2002-12-30
K024107 FEMOSTOP FEMORAL COMPRESSION SYSTEM Radi Medical Systems AB DXC Class II 2002-12-24
K021509 HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 Hygia Health Services, Inc. JOW Class II 2002-12-24
K023370 CHEETAH I.V.D.S., MODEL 2002P Cheetah Medical, Inc. DQK Class II 2002-12-24
K023154 VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 Vascular Control Systems, Inc. DXC Class II 2002-12-20
K022660 BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 Biocheck, Inc. DRR Class II 2002-12-19
K024108 SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM Siemens Medical Solutions USA, Inc. MHX Class II 2002-12-18
K023112 PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 Problem Solving Concepts, Inc. DQK Class II 2002-12-17
K023185 ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 Sulzer Carbomedics, Inc. KRH Class II 2002-12-17
K023132 JOSTRA MECC SYSTEM Jostra AG KFM Class II 2002-12-17
K022762 JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 Jomed, Inc. DQX Class II 2002-12-16
K023938 MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 Hutchinson Technology, Inc. MUD Class II 2002-12-13
K022732 INFANT/CHILD REDUCED ENERGY ELECTRODES Medtronic Physio-Control Corp. MKJ Class III 2002-12-13
K021682 OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC Omron Healthcare, Inc. DXN Class II 2002-12-12
K023180 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS Vanguard Medical Concepts, Inc. NLH Class II 2002-12-12
K023803 MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS Biotronik, Inc. DTB Class III 2002-12-11
K023880 CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER ETHICON, Inc. DWF Class II 2002-12-11
K014277 KSEA DEPLOYABLE CARDIOVASCULAR CLAMP KARL STORZ Endoscopy-America, Inc. DXC Class II 2002-12-11
K023320 AGILTRAC .035 PERIPHERAL DILATATION CATHETER Guidant Corp. DQY Class II 2002-12-10
K023016 NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE Nicore Equipment & Leasing, Inc. DRN Class II 2002-12-04
K023871 M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY Philips Medical Systems MHX Class II 2002-12-04
K023700 PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE Precision Vascular Systems, Inc. DQX Class II 2002-12-04
K023251 PEDIATRIC ARTERIAL CANNULA Polystan A/S DWF Class II 2002-12-04
K020440 NEWCOR Siemens Medical Systems, Inc. DQK Class II 2002-12-03
K023798 MODIFICATION TO ENVOY PATIENT MONITOR Mennen Medical , Ltd. DSI Class II 2002-12-03
K023380 T-WAVE ALTERMANS (TWA) ALGORITHM OPTION General Electric Medical Systems Information Techn DQK Class II 2002-12-03
K022640 SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM Bacchus Vascular, Inc. MCW Class II 2002-12-02
K023514 TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH) Bacchus Vascular, Inc. QEY Class II 2002-12-02
K023674 PHILIPS DRUG CALCULATOR SOFTWARE Philips Medical Systems MHX Class II 2002-11-29
K022918 ADAPTERS WITH X-COATING Terumo Cardiovascular Systems Corporation DTL Class II 2002-11-27
K021363 ENDOVASCULAR GUIDE WIRE Stereotaxis, Inc. DQX Class II 2002-11-27
K022903 CHILLBUSTER Microtek Medical, Inc. DWJ Class II 2002-11-27
K022236 RECOVERY FILTER SYSTEM, MODEL RF-048F C.R. Bard, Inc. DTK Class II 2002-11-27
K023681 RENEGADE STC 18 MICROCATHETER Boston Scientific Corp DQO Class II 2002-11-26
K023056 CIRCUIT TUBINGS WITH X-COATING Terumo Cardiovascular Systems Corp. DWF Class II 2002-11-26
K021397 EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION Biosphere Medical, Inc. NAJ Class II 2002-11-22
K023622 STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 Stockert Instrumente GmbH DWF Class II 2002-11-21
K023573 WIZAIR COMPRESSION SYSTEM Medical Compression Systems (Dbn) , Ltd. JOW Class II 2002-11-21
K022916 BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211 K-Jump Health Co., Ltd. DXN Class II 2002-11-21
K023698 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O Philips Medical Systems MHX Class II 2002-11-19
K023749 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) Philips Medical Systems DRG Class II 2002-11-19
K022783 TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM Tensys Medical, Inc. DXN Class II 2002-11-19
K013913 PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM Medtronic Percusurge, Inc. NFA Class II 2002-11-15
K011518 VITALSAT SERIES Beta Biomed Services, Inc. DQA Class II 2002-11-15
K022753 REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS Medical Device Services JOW Class II 2002-11-14
K023503 SKINTACT ECG ELECTRODE Leonhard Lang GmbH DRX Class II 2002-11-14
K021470 SEER LIGHT COMPACT DIGITAL HOLTER RECORDER General Electric Medical Systems Information Techn MWJ Class II 2002-11-14
K022740 DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE Datex-Ohmeda MLD Class II 2002-11-14
K023504 MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER Cook, Inc. LIT Class II 2002-11-13
K023431 QUANTIX/ND DEVICE Cardiosonix, Ltd. DPW Class II 2002-11-13
K021240 EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200 Eikon Healthcare Device Corp. DXN Class II 2002-11-08
K020715 PHILIPS M5066A AND M5068A Philips Medical Systems MKJ Class III 2002-11-08
K023507 MODIFICATION TO GELBFISH VASCULAR DILATORS Vascumetrix, LLC DRE Class II 2002-11-08
K021239 EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M Eikon Healthcare Device Corp. DXN Class II 2002-11-08
K020003 ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE Bio Protech, Inc. DRX Class II 2002-11-07
K014218 OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' Dolphin Medical, Inc. DQA Class II 2002-11-07
K023402 8F LAUNCHER GUIDE CATHETER Medtronic Vascular DQY Class II 2002-11-06
K022634 CO-AXIAL INTRODUCER NEEDLE Promex, Inc. DYB Class II 2002-11-06
K023418 HEARTONE EVENT RECORDER AND TRANSMITTER Aerotel Medical Systems (1998) , Ltd. DXH Class II 2002-11-06
K023569 SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS Siemens Medical Solutions USA, Inc. MHX Class II 2002-11-04
K023497 DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE Datex-Ohmeda MSX Class II 2002-11-04
K022047 PHLEBOTEST 2000 Osborn Medical Corp. JOM Class II 2002-11-04
K023616 PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) Ivy Biomedical Systems, Inc. DRT Class II 2002-11-04
K023447 MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F) St Jude Medical DYB Class II 2002-10-31
K023495 WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK) Welch Allyn, Inc. DXN Class II 2002-10-31
K023303 EXPORT ASPIRATION CATHETER Medtronic Vascular NFA Class II 2002-10-29
K023300 HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J Guidant Corp. DQX Class II 2002-10-28
K021210 ARTERIA OCCLUSION BALLOON Arteria Medical Science, Inc. MJN Class II 2002-10-28
K022513 MEDCOMP VASCU-SHEATH INTRODUCER SET Medcomp DYB Class II 2002-10-25
K023223 MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER Lumend, Inc. DQY Class II 2002-10-24
K023475 CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES Nihon Kohden America, Inc. MHX Class II 2002-10-24
K022540 CARDIO ID+(RZ153+) Rozinn Electronics, Inc. DSH Class II 2002-10-24
K022450 INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY Dideco S.P.A. DTZ Class II 2002-10-22
K023055 BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-200 Vsm Medtech , Ltd. DXN Class II 2002-10-22
K021608 SMITHWICK CAROTID SHUNT Implantable Devices DXC Class II 2002-10-22
K023116 CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B Cordis Corp. DTK Class II 2002-10-18
K023099 AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP Biotronik, Inc. DTB Class III 2002-10-18
K022754 S&T SINGLE USE MICRO ANASTOMOSIS CLAMP S & T AG DXC Class II 2002-10-16
K022357 TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 Boston Scientific, Target DQX Class II 2002-10-16
K012537 REPROCESSED IMAGING CATHETERS Sterilmed, Inc. OWQ Class II 2002-10-11
K022117 MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 Merit Medical Systems, Inc. DRC Class II 2002-10-11
K021087 HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE Erecords Limited DQD Class II 2002-10-11

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