meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
1986-05-08

Clearances · page 158 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K860790 BIOMECCA CARETAKER 1000 & 2000 Biomecca Australia , Ltd. DPS Class II 1986-05-08
K860652 ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS Hewlett-Packard Co. JOP Class II 1986-05-08
K854610 VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER Gish Biomedical, Inc. DQY Class II 1986-05-08
K841596 MEADOS INTRAORTIC GRAFT Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1986-05-08
K854433 ECG MONITORING/DEFIBRILLATION ELECTRODE Andover Medical, Inc. DRX Class II 1986-05-08
K860805 PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 Gould, Inc. DQO Class II 1986-05-08
K854840 PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A Ivy Biomedical Systems, Inc. DPS Class II 1986-05-07
K854596 TDK ECG ELECTRODE MEL-08-09 & -11 Tdk Corp. DRS Class II 1986-05-07
K853996 DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE Transamerica Delaval, Inc. DRS Class II 1986-05-07
K860427 KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT Kontron Instruments, Inc. DSP Class II 1986-05-07
K853567 DJP UNIPOLAR Biotronik Sales, Inc. DTB Class III 1986-05-07
K853566 DJ UNIPOLAR Biotronik Sales, Inc. DTB Class III 1986-05-07
K854431 MEADOX MEDICALS INC. GRAFT SIZER Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1986-05-07
K854356 STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE Fontaine Industries, Inc. DQD Class II 1986-05-05
K861165 PHARMASEAL DUAL LUMEN CATHETER American Pharmaseal Div. Ahsc DQY Class II 1986-05-05
K861082 CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST Cordis Corp. DYB Class II 1986-05-05
K861409 SYNCARE TEMPORARY CARDIAC PACING WIRE Gyneco, Inc. LDF Class II 1986-05-05
K860435 MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER Multigon Industries, Inc. DPT Class II 1986-05-05
K861240 BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER Mountain View Medical DSI Class II 1986-05-02
K860161 HEART CATHETERIZATION TRAY Medical Design Concepts, Inc. DRE Class II 1986-05-02
K860950 SCM-400 HOLTER SYSTEM Fukuda Denshi USA, Inc. DSI Class II 1986-05-02
K861140 PROGRAMALITH III PULSE GENERATOR Pacesetter Systems DXY Class III 1986-05-02
K860526 NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH Nova Medical Specialties DXO Class II 1986-05-02
K852250 595 ARRHYTHMIA MONITORING SYSTEM Burdick Corp. DSI Class II 1986-05-02
K860204 ANGIOMAT 6000 Mallinckrodt Group, Inc. DXT Class II 1986-05-02
K854196 DCI MODEL EP-2 CLINICAL STIMULATOR Digital Cardiovascular Instruments, Inc. DRO Class II 1986-05-01
K860470 DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST Del Mar Avionics DSI Class II 1986-04-30
K860551 ETP 180 CARDIAC PACEMAKER (EXTERNAL) Biotronics Corp. DRO Class II 1986-04-30
K860676 HEARTSTART 2000 First Medical Devices Corp. MKJ Class III 1986-04-30
K860471 DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER Del Mar Avionics DSI Class II 1986-04-30
K861008 PERCUTANEOUS CATHETERS Micor, Inc. DQY Class II 1986-04-29
K855201 BARD PARKER PERFUSION CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic DQY Class II 1986-04-29
K860834 SPACELABS MEDICAL WORKSTATION Spacelabs, Inc. DSI Class II 1986-04-29
K861176 MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER Intermedics, Inc. DTB Class III 1986-04-29
K860523 CARDIO-COOL Bio-Vascular, Inc. DTR Class II 1986-04-29
K860539 SARNS OXYGENATOR SYSTEM 3M Health Care, Sarns DTZ Class II 1986-04-29
K860898 SUBCLAVIAN INTRODUCER SET Infusaid Corp. DYB Class II 1986-04-29
K854370 MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR Nihon Kohden America, Inc. DXN Class II 1986-04-28
K860841 GUIDE WIRE INTRODUCER Target Therapeutics DQX Class II 1986-04-28
K860287 PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 Healthcheck Corp. DXN Class II 1986-04-28
K860546 DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 Pacesetter Systems KRG Class III 1986-04-23
K860767 MODEL E 600 ELECTROCARDIOGRAPH Kone Instruments, Inc. DSI Class II 1986-04-23
K860015 MODIFIED CHERNE CAD DETECTOR Cherne Industries, Inc. DXG Class II 1986-04-23
K860842 ANGIOJECT Target Therapeutics DXT Class II 1986-04-23
K860840 GUIDED WIRE TORQUER Target Therapeutics DQX Class II 1986-04-23
K860958 CATHETER INTRODUCER Target Therapeutics DYB Class II 1986-04-23
K861110 MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER Intermedics, Inc. DTB Class III 1986-04-23
K854757 5000 SERIES ECG ELECTRODES Alternative Design Systems, Inc. DRX Class II 1986-04-23
K860429 MEADOX SURGIMED GUIDE CATHETER Meadox Surgimed, Inc. DQO Class II 1986-04-23
K861009 BIPOLAR CARDIAC PACEMAKER, MODEL 110 Cardiac Control Systems, Inc. DXY Class III 1986-04-23
K854639 BIOMECCA CENTRAL CS1 Biomecca Australia , Ltd. DRT Class II 1986-04-17
K860212 CARDIOFAX ECG-6353 Nihon Kohden America, Inc. DPS Class II 1986-04-17
K854201 OMRON DIGITAL BP MONITOR HEM-700CP Omron Tateisi Electronics Co. DXN Class II 1986-04-17
K853774 EM ELECTRODE Electromed Intl., Ltd. DRX Class II 1986-04-17
K854941 PMS PERCUTANEOUS PUNCTURE NEEDLE Professional Medical Services DYB Class II 1986-04-16
K854912 ANGIOMED GUIED WIRES Angiomed U.S., Inc. DQX Class II 1986-04-16
K855061 CURITY PERCUTANEOUS CATHETER INSERTION KIT The Kendal Co. DYB Class II 1986-04-16
K855060 CURITY PERCUTANEOUS CATHETER INSERTION TRAY The Kendal Co. DYB Class II 1986-04-16
K860175 CD-200 CARDIAC MONITOR Cardio Display Corp. DPS Class II 1986-04-15
K854996 ULTRASONIC COUPLANT GEL Johnson & Johnson Professionals, Inc. JOP Class II 1986-04-14
K853706 BOMED-CDM Bomed Medical Mfr., Ltd. DSB Class II 1986-04-14
K853939 ECG-ELECTRODE(SWAROMED) D. Swarovski & Co. DRX Class II 1986-04-11
K854269 MODEL 509A PHYSIOCORDER AMBULATORY RECORDER Del Mar Avionics DSH Class II 1986-04-11
K854866 LONG TERM RECORDER RAG 1200 Nihon Kohden America, Inc. DSF Class I 1986-04-09
K860699 RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES Intracath, Inc. DQY Class II 1986-04-02
K860298 STABLELINE Cardio Metrics, Inc. KRI Class I 1986-04-02
K852973 UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 Ela Medical, Inc. DXY Class III 1986-03-31
K860283 AMI CARDIO-PAD Andover Medical, Inc. DRO Class II 1986-03-31
K854831 VALVOKIT Novamed Products, Inc. DYB Class II 1986-03-31
K860985 MODEL 366-19 ADAPTAID ADAPTER SLEEVE Intermedics, Inc. DTB Class III 1986-03-31
K860291 TUBING CONNECTORS Biomedical Exports, Inc. DTL Class II 1986-03-31
K860832 MODEL 366-08 ADAPTAID CONNECTOR ADAPTER Intermedics, Inc. DTD Class II 1986-03-31
K860986 MODEL 366-09 ADAPTAID ADAPTER SLEEVE Intermedics, Inc. DTB Class III 1986-03-31
K854830 ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES Advanced Cardiovascular Systems, Inc. DQX Class II 1986-03-31
K860024 FUKUDA DENSHI CARDIMAX FCP-211 Brentwood Instruments, Inc. DSI Class II 1986-03-31
K860533 (.O38) HI-TORQUE GUIDE WIRES Target Therapeutics DQX Class II 1986-03-31
K854319 SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER Shiley, Inc. LIT Class II 1986-03-31
K855082 DEFIB-PADS Conmedcorp LDD Class II 1986-03-31
K860339 PERCUTANEOUS CATHETERS Micor, Inc. DQY Class II 1986-03-31
K854984 CUP MONITORING KIT CVPK-14 Medical Components, Inc. DQY Class II 1986-03-31
K860167 PRODIGY AND PRODIGY PLUS Cardiodata Corp. DSI Class II 1986-03-31
K860580 ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP Advanced Cardiovascular Systems, Inc. DQO Class II 1986-03-31
K860149 VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015 Dlp, Inc. DWF Class II 1986-03-31
K860806 REGULATED PRESSURE INJECTOR Target Therapeutics DXF Class II 1986-03-31
K860570 ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE Parke-Davis Co. KRA Class II 1986-03-31
K853669 MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL Hewlett-Packard Co. DSI Class II 1986-03-31
K855015 NONINVASIVE TEMP. PACEMAKER NTP-1000 Zmi Corp. DRO Class II 1986-03-31
K860432 PERCUTANEOUS INTRODUCER KIT Cormed, Inc., Sub. C.R.Bard, Inc. DYB Class II 1986-03-31
K855125 PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM Honeywell, Inc. DRT Class II 1986-03-26
K854023 NORELCO ELECTRONIC DIGITAL BP METER HC3501 Philips Park DXQ Class II 1986-03-26
K855229 CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM Vingmed, Inc. DXK Class II 1986-03-25
K853599 LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI Litton Datamedix DXN Class II 1986-03-21
K855147 MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS Medtronic Vascular DXY Class III 1986-03-17
K852574 WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C Welch Allyn, Inc. DXN Class II 1986-03-13
K854198 PE-3000 PULSE RATE MONITOR Quantum Life Systems, Inc. DRT Class II 1986-03-13
K853115 SONOLAYER S, SSH-60A/SDS-60A Toshiba Medical Systems DXK Class II 1986-03-12
K853318 PATIENT MONITOR PB240 Puritan Bennett Corp. DRT Class II 1986-03-11
K854881 SIRECUST 341 AND 341R Siemens Medical Solutions USA, Inc. DRT Class II 1986-03-11
K854918 MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-03-11
K860249 THE HOLTER REPORTER (TM) Applied Cardiac Systems DPS Class II 1986-03-11

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