meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
2000-11-21

Clearances · page 101 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K003424 PINNACLE R/O II OR RADIFOCUS INTRODUCER II Terumo Medical Corp. DYB Class II 2000-11-21
K002725 MICROPAQ, MODELS 402 AND 404 Protocol Systems, Inc. DRT Class II 2000-11-21
K992529 TISSUE SPECTROSCOPE Vital Medical , Ltd. DPW Class II 2000-11-17
K001663 FRONT-LOAD POLYPROPYLENE SYRINGE Medrad, Inc. DXT Class II 2000-11-16
K002530 WELCH ALLYN SPOT CHECK DEVICE Welch Allyn, Inc. DXN Class II 2000-11-14
K003349 ALLON 2001 MODIFIED Mtre Advanced Technology , Ltd. DWJ Class II 2000-11-13
K002687 ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 Zynergy Cardiovascular, Inc. LDF Class II 2000-11-09
K003179 SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM Siemens Medical Solutions USA, Inc. DSI Class II 2000-11-09
K003167 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2000-11-08
K002459 PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH Agilent Technologies, Inc. DPS Class II 2000-11-08
K003244 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2000-11-08
K002473 WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES Nihon Kohden America, Inc. DPS Class II 2000-11-08
K003220 PERSONAL ECG TRANSMITTER, MODEL CG-6550 Card Guard Scientific Survival , Ltd. DXH Class II 2000-11-08
K002707 PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING Precision Vascular Systems, Inc. DQX Class II 2000-11-08
K001433 CNS-9300 SERIES CENTRAL STATION Nihon Kohden America, Inc. MHX Class II 2000-11-07
K003070 ETHIBOND EXCEL VALVE LOOP SUTURE ETHICON, Inc. DXZ Class II 2000-11-07
K001788 ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200 Erecords Enterprises DQD Class II 2000-11-03
K003052 NUMED TYSHAK II AND Z-MED II PTV CATHETERS NuMED, Inc. LIT Class II 2000-11-01
K001948 CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM Hypertension Diagnostics, Inc. DXN Class II 2000-11-01
K991783 AB-180 XC SYSTEM, MODEL AB-180XC Cardiacassist, Inc. KFM Class II 2000-11-01
K003114 NUMED TYSHAK AND Z-MED PTV CATHETERS NuMED, Inc. LIT Class II 2000-11-01
K003282 FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H Sein Electronics Co., Ltd. DXN Class II 2000-11-01
K003159 CORDIS SLALOM PTA BALLOON CATHETER Cordis Corp. LIT Class II 2000-10-30
K002676 ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER Guidant Cardiac and Vascular Surgery DYB Class II 2000-10-30
K000638 RESPONDER 3000 Ge Medical Systems Information Technologies GmbH MKJ Class III 2000-10-30
K001972 ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK Visicu, Inc. MSX Class II 2000-10-27
K002577 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS Medivance, Inc. DWJ Class II 2000-10-26
K002310 CARDIOBEEPER CB12/12, MODEL CB12/12 Meridian Medical Technologies , Ltd. DXH Class II 2000-10-25
K003004 OSCAR 2, MODEL 222 Suntech Medical Instruments, Inc. DXN Class II 2000-10-25
K001693 LIFE SCOPE P, MODEL BSM-4100 SERIES Nihon Kohden America, Inc. MHX Class II 2000-10-24
K002949 MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC Datascope Corp. DSP Class II 2000-10-20
K003107 M2376A DEVICELINK SYSTEM Agilent Technologies, Inc. MWI Class II 2000-10-19
K002957 SOLAR SPO2 MODULE WITH MASIMO SET General Electric Medical Systems Information Techn DQA Class II 2000-10-18
K002967 M2376A DEVICELINK SYSTEM, MODEL M2376A Agilent Technologies, Inc. MWI Class II 2000-10-18
K002204 PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V Pace Medical DTE Class II 2000-10-18
K000855 GUNTHER TULIP VENA CAVA MREYE FILTER SET Cook, Inc. DTK Class II 2000-10-18
K002534 EUPALAMUS DEFLECTABLE STYLET, MODEL 01545 Eupalamus, LLC DRB Class II 2000-10-18
K980974 SAFE MINI Polystan A/S DTZ Class II 2000-10-13
K002882 HL168B Health & Life Co., Ltd. DXN Class II 2000-10-13
K001578 ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER AngioDynamics, Inc. DQO Class II 2000-10-13
K002690 MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 Nonin Medical, Inc. DQA Class II 2000-10-11
K002497 MODEL 4810 ANALYZER OUTPUT ADAPTER Pace Medical DTC Class II 2000-10-10
K002496 MODEL 4815 ADAPTER Pace Medical DTN Class II 2000-10-10
K002939 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER Masimo Corp. DQA Class II 2000-10-06
K002751 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2000-10-05
K002137 CATHCOR DESKTOP Siemens Elema AB DQK Class II 2000-10-05
K002478 S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 Datex-Ohmeda, Inc. MHX Class II 2000-10-05
K002857 ELS CANNULA (KIT), MODEL M1210-88,M1510-88 Jostra AG DWF Class II 2000-10-05
K002289 INQWIRE DIAGNOSTIC GUIDE WIRE Merit Medical Systems, Inc. DQX Class II 2000-10-04
K002074 AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES H&C Medical Devices Spa DPS Class II 2000-10-04
K002962 PRESSURE WIRE SENSOR, MODEL 12003/12303 Radi Medical Systems AB DQX Class II 2000-10-04
K002723 REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA Micro Therapeutics, Inc. KRA Class II 2000-09-28
K991977 TYSHAK, MODEL 102 AND Z-MED, MODEL 302 NuMED, Inc. LIT Class II 2000-09-27
K002767 COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE Semler Technologies, Inc. DXC Class II 2000-09-27
K002346 WIRE, GUIDE, CATHETER, MODEL QSW1000 Medtronic Ave, Inc. DQX Class II 2000-09-27
K002360 CLOUD CUFF Parts Port, Ltd. DXQ Class II 2000-09-26
K001244 BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D Citizen Watch Co., Ltd. DXN Class II 2000-09-26
K000512 OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 Cas Medical Systems, Inc. DXQ Class II 2000-09-26
K000277 CONSTELLATION CATHETERS Boston Scientific Corp MTD Class II 2000-09-26
K002030 OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES Invivo Research, Inc. MWI Class II 2000-09-26
K001992 ILT 0.014 CATHETER, MODEL C114NL2 Intra Luminal Therapeutics, Inc. DQY Class II 2000-09-25
K001926 VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES Thoratec Laboratories Corp. DYB Class II 2000-09-22
K002029 ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION Zoll Medical Corp DXN Class II 2000-09-21
K002248 DINAMAP PRO 1000 MONITOR, MODEL 1000 Critikon Company, LLC DXN Class II 2000-09-21
K000825 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER Medi-Dyne, Inc. DQO Class II 2000-09-21
K002004 ZYBIT Zymed Medical Instrumentation DXH Class II 2000-09-21
K000664 VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS Baxter Healthcare Corp DXG Class II 2000-09-20
K002750 HL168T Health & Life Co., Ltd. DXN Class II 2000-09-18
K002366 QUEST MPS BACK-UP SYSYEM Quest Medical, Inc. DWF Class II 2000-09-18
K980937 NICORE MODEL ESP -1 Nicore Equipment & Leasing, Inc. DRN Class II 2000-09-15
K001842 ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 Somanetics Corp. DQA Class II 2000-09-15
K002544 MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM Oxford Instruments DQK Class II 2000-09-13
K002682 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2000-09-13
K992476 PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS Pilling Weck Surgical MWS Class I 2000-09-13
K002591 COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR Cobe Cardiovascular, Inc. DTP Class II 2000-09-13
K002722 DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 Jawon Medical Co., Ltd. DXN Class II 2000-09-11
K002416 GOLDEN-RULE SCALING CATHETER Medical Device Technologies, Inc. DQO Class II 2000-09-11
K001725 HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A Agilent Technologies, Inc. MKJ Class III 2000-09-08
K002477 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. DQA Class II 2000-09-08
K001995 SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER Qrs Diagnostic, LLC DQA Class II 2000-09-08
K000830 CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE California Medical Laboratories, Inc. DWF Class II 2000-09-07
K002026 CAPIOX ARTERIAL FILTER Terumo Medical Corp. DTM Class II 2000-09-06
K000743 BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 Boston Scientific Scimed, Inc. DQO Class II 2000-09-06
K002655 DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 Meditec Co., Ltd. DXN Class II 2000-09-06
K002574 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT Masimo Corp. DQA Class II 2000-09-06
K002158 S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE Datex-Ohmeda, Inc. MHX Class II 2000-09-06
K001149 AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK Augustine Medical, Inc. DWJ Class II 2000-09-06
K001898 VASOTRAX Medwave, Inc. DXN Class II 2000-08-31
K001134 GAZELLE BALLOON DILATATION CATHETER Boston Scientific Corp LIT Class II 2000-08-31
K991864 ROTAFLOW CENTRIFUGAL PUMP SYSTEM Jostra Medizintechnik AG KFM Class II 2000-08-31
K002333 BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220 Biosense Webster, Inc. DRF Class II 2000-08-31
K000517 LIFE SCOPE EC, MODEL BSM-1102 Nihon Kohden America, Inc. MHX Class II 2000-08-31
K984570 MINOLTA PULSOX-3/MINOLTA PULSOX-3I In-X Corp. DQA Class II 2000-08-30
K002365 DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET Datascope Corp. DYB Class II 2000-08-25
K002287 WIZAIR COMPRESSION SYSTEM Medical Compression Systems (Dbn) , Ltd. JOW Class II 2000-08-25
K002388 EHC500 DESKTOP PATIENT STATION, MODEL EHC500 Cybercare, Inc. DXN Class II 2000-08-25
K002206 HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO Guidant Corp. DQX Class II 2000-08-24
K002238 CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING Terumo Cardiovascular Systems Corp. DTN Class II 2000-08-22
K002223 EPIC SPO2 FINGER SENSOR, MODEL E412-20 Epic Medical Equipment Services, Inc. DQA Class II 2000-08-22
K002230 CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 Cambridge Heart, Inc. DRX Class II 2000-08-18

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