meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
1989-05-19

Clearances · page 144 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K891000 MODIFIED EXTERNAL PAD Instromedix, Inc. DWS Class I 1989-05-19
K884804 THE COACH Promark, Inc. DRT Class II 1989-05-19
K891230 MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. Medtronic Blood Systems, Inc. DTZ Class II 1989-05-19
K892113 Q5000 PC WORKSTATION Quinton, Inc. DQK Class II 1989-05-18
K885348 A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL Mallinckroot, Inc. DQO Class II 1989-05-15
K884628 HARBORIN CENTRAL VENOUS CATHETER Harbor Medical Devices, Inc. DQR Class II 1989-05-15
K890005 TYPE 9225 NIBP S & W Medico Teknik DXN Class II 1989-05-11
K891148 MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM Del Mar Avionics DSI Class II 1989-05-11
K890575 ACCUTHERM PTS-200 Medical Repackers Co. DWJ Class II 1989-05-05
K890791 SIEMENS SIRECUST 730 PATIENT MONITOR Siemens Medical Electronics DPS Class II 1989-05-02
K890980 MODIFIED STOCKERT-SHILEY VENOUS CATHETER Shiley, Inc. DWF Class II 1989-05-01
K884980 F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM S & W Medico Teknik DRX Class II 1989-05-01
K885166 ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES Zmi Corp. DRO Class II 1989-05-01
K890808 SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV 3M Company DTZ Class II 1989-05-01
K884117 TYPE 9210 ECG SYSTEM ATHENA S & W Medico Teknik DRT Class II 1989-04-26
K884116 TYPE 9040 SYSTEM ATHENA S & W Medico Teknik DPS Class II 1989-04-26
K884121 TYPE 9266 SAO2 SYSTEM ATHENA S & W Medico Teknik DQA Class II 1989-04-25
K884118 TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA S & W Medico Teknik DSK Class II 1989-04-25
K884122 TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA S & W Medico Teknik DXG Class II 1989-04-25
K890420 USCI 7F GUIDE CATHETER C.R. Bard, Inc. DQO Class II 1989-04-24
K890126 KAMED STETHOSCOPE D.R.G. LDE Class I 1989-04-21
K890527 ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS Medtronic Vascular DTB Class III 1989-04-21
K883948 MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER NuMED, Inc. DYG Class II 1989-04-21
K884354 IMAGER FLUSH CATHETERS Medi-Tech, Inc. DQO Class II 1989-04-21
K890330 MEDILOG 6000-FD REPORT GENERATOR Oxford Medilog, Inc. DSI Class II 1989-04-20
K891104 CD TELEMETRY SYSTEMS Marquette Electronics, Inc. DRG Class II 1989-04-19
K885204 HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS) Mennen Medical, Inc. DSI Class II 1989-04-19
K884697 HEPARIN BONDING FOR CATHETERS Daig Corp. DTB Class III 1989-04-19
K890580 LIPID STOPCOCK North American Instrument Corp. DTL Class II 1989-04-19
K884327 EXCEL Y-CONNECTOR CAT. #E-201 Medical Profiles, Inc. LIT Class II 1989-04-19
K884938 VITAL SIGNS MONITOR Tico Medical Instruments, Inc. DSK Class II 1989-04-19
K890338 MEDILOG EDITOR Oxford Medilog, Inc. DSI Class II 1989-04-19
K884913 MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) Merit Medical Systems, Inc. DXT Class II 1989-04-18
K890432 DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) Deknatel, Inc. DWS Class I 1989-04-13
K890904 MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP Shiley, Inc. DWB Class II 1989-04-12
K890898 MODEL 611101 CONTRAST INJECTION DEVICE Medtronic Versaflex, Inc. DXT Class II 1989-04-12
K890707 PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL Dlp, Inc. DWS Class I 1989-04-10
K884524 HTS 220 CARDIAC MONITOR Life Sensing Instrument Company, Inc. DSI Class II 1989-04-10
K883880 KATZEN THROMBOLYSIS GUIDEWIRE Medi-Tech, Inc. DQX Class II 1989-04-06
K882206 SUPERMON ARRHYTHMIA MODULE 7270 Kontron Instruments, Inc. DSI Class II 1989-04-05
K884560 SCIMED ECMOTHERM(TM) HEAT EXCHANGER Scimed Life Systems, Inc. DTR Class II 1989-04-03
K890077 TRAUMAFUSE RAPID INFUSION DEVICE The Traumafuse Co. DTN Class II 1989-04-03
K882507 ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO. Advanced Cardiovascular Systems, Inc. DQX Class II 1989-03-31
K890453 REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES Dlp, Inc. DWZ Class II 1989-03-31
K890481 7610 COLORVIEW SLAVE SCOPE Marquette Electronics, Inc. DPS Class II 1989-03-31
K885177 PHYSIOGARD SM 785 Adam DPS Class II 1989-03-31
K890412 MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS Intermedics, Inc. DTB Class III 1989-03-28
K890411 MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS Intermedics, Inc. DTB Class III 1989-03-28
K885267 VS-1 MODEL NUMBER 251K PULSE GENERATOR Pacesetter Systems DXY Class III 1989-03-28
K891075 BARD NEONATAL ECG MONITORING ELECTRODE C.R. Bard, Inc. DRX Class II 1989-03-22
K890547 SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS Pacesetter Systems DTB Class III 1989-03-22
K890753 SATLITE TRANS PORTABLE PULSE OXIMETER Datex Division Instrumentarium Corp. DQA Class II 1989-03-22
K884866 TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 Oscor Medical Corp. LDF Class II 1989-03-22
K882274 10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC Kontron Instruments, Inc. DSP Class II 1989-03-20
K882508 9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON Kontron Instruments, Inc. DSP Class II 1989-03-20
K885237 ACS SELECTIVE INFUSION CATHETER Advanced Cardiovascular Systems, Inc. DQY Class II 1989-03-16
K884216 506 NON-INVASIVE VITAL SIGNS MONITOR Criticare Systems, Inc. DSI Class II 1989-03-16
K885137 ASTRO TRACE (MODEL AT-02) The LE Blanc Corp. DSA Class II 1989-03-15
K890647 MEDILOG 9000-II AMBULATORY RECORDER Oxford Medilog, Inc. DSH Class II 1989-03-15
K890201 RADIOLUCENT ECG ELECTRODE MODEL NO: 1680 Medtronic Vascular DRX Class II 1989-03-15
K890325 USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP C.R. Bard, Inc. LIT Class II 1989-03-15
K890504 CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS Gish Biomedical, Inc. JOD Class II 1989-03-10
K881604 VENA CAVA FILTER Vena-Tech, Inc. DTK Class II 1989-03-10
K890277 HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT Oscor Medical Corp. DYB Class II 1989-03-10
K890785 ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE Cardiac Pacemakers, Inc. DXY Class III 1989-03-10
K884981 F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM S & W Medico Teknik DRX Class II 1989-03-10
K884982 M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68 S & W Medico Teknik DRX Class II 1989-03-10
K885247 STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR Baxter Healthcare Corp LIT Class II 1989-03-10
K884455 MODEL 702 ECG/RESPIRATION/TEMPERATURE Ivy Biomedical Systems, Inc. DRT Class II 1989-03-09
K884897 FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER Mennen Medical, Inc. DSF Class I 1989-03-09
K883903 NR2000 CARDIAC MONITOR Nirad , Ltd. DPS Class II 1989-03-09
K890558 WELLSHIRE BASELINK American Executive Technology DXH Class II 1989-03-09
K884504 ELECTRODE GEL Herbert Stanley Co. DPS Class II 1989-03-09
K884983 M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55 S & W Medico Teknik DRX Class II 1989-03-09
K884984 M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40 S & W Medico Teknik DRX Class II 1989-03-09
K884106 SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL Siemens Medical Solutions USA, Inc. DSI Class II 1989-03-06
K885281 VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION Baxter Healthcare Corp KRA Class II 1989-03-03
K882401 STONY BROOK MODEL EECP-MC1 Stony Brook Trading and Development Corp. DRN Class II 1989-03-03
K890508 WELLSHIRE EMLINK MODEL 1000 American Executive Technology DXH Class II 1989-03-02
K890353 SMDS460 SURGICAL MONITOR DISPLAY SYSTEM Vidco, Inc. DXJ Class II 1989-03-02
K884592 ASTRO TRACE (MODEL AT-01) The LE Blanc Corp. DSA Class II 1989-03-02
K890299 KONTRON PULSE OXIMETER 7840 Kontron Instruments, Inc. DQA Class II 1989-03-02
K884822 MODEL OX-1 OXYGEN SATURATION MODULE Colin Medical Instruments Corp. DQA Class II 1989-03-02
K890492 PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH. Endosonics Corp. DXO Class II 1989-03-02
K890024 SARNS VENT CATHETER 3M Company DWF Class II 1989-03-02
K884896 BP-308 MARK II Colin Medical Instruments Corp. DPS Class II 1989-02-23
K885306 NUPREP Weaver & Co. DRX Class II 1989-02-23
K890079 LIFEPAK 10 DEFIBRILLATOR/MONITOR Physio-Control Corp. LDD Class II 1989-02-23
K884096 PATIENT MONITOR MODEL 701 Ivy Biomedical Systems, Inc. DRT Class II 1989-02-23
K884050 CNS-8200A CENTRAL NURSES STATION Nihon Kohden America, Inc. DQA Class II 1989-02-23
K885186 HEARTSTART 2000 DEFIBRILLATION ELECTRODE Laerdal Mfg. Corp. LDD Class II 1989-02-23
K890461 CARDIOBEEPER IV Survival Technology, Inc. DXH Class II 1989-02-23
K884885 BP-408 MARK II Colin Medical Instruments Corp. DXN Class II 1989-02-23
K885154 INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM Medtronic Blood Systems, Inc. KRJ Class II 1989-02-22
K884478 DAIG COLLAPSIBLE STERILE SLEEVE Daig Corp. DQR Class II 1989-02-22
K884494 DAIG OBTURATOR, CATHETER INTRODUCER Daig Corp. DYB Class II 1989-02-22
K884159 SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT Mallinckroot, Inc. DYB Class II 1989-02-22
K884811 ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS Telectronics and Control Pacing Systems DTB Class III 1989-02-22
K890165 FORCEPS-ORTHOPEDIC Dhason Brothers, Inc. LXN Class I 1989-02-13
K885240 MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD Tpl-Cordis, Inc. DTB Class III 1989-02-10

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