meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
40
Latest Decision
1986-09-23

Clearances · page 156 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K862951 SPACELABS SERIES 90700 PATIENT MONITORS Spacelabs, Inc. DPS Class II 1986-09-23
K863178 UMI STEERABLE TORQUE GUIDE WIRE Universal Medical Instrument Corp. DQX Class II 1986-09-19
K862983 ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES Target Therapeutics DQX Class II 1986-09-19
K862053 MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-09-19
K863322 MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS Quinton, Inc. DQY Class II 1986-09-19
K862054 MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-09-19
K863116 CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH) Nihon Kohden America, Inc. DPS Class II 1986-09-17
K862618 SKINTACT AG ELECTRODES Leon H. Lang Co. DRX Class II 1986-09-15
K861808 VASCUTEK VASCULAR PROSTHESES, EXTRA SOFT/LOW WOVEN Cobe Laboratories, Inc. DSY Class II 1986-09-15
K862836 STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE Shiley, Inc. DXS Class II 1986-09-12
K861621 CARDIAN II CR45A Cardiac Recorders, Ltd. DRT Class II 1986-09-12
K862426 PULSE OXIMETER Draeger Medical, Inc. DPZ Class II 1986-09-11
K862673 MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER Medtronic Vascular DQO Class II 1986-09-11
K862360 ACS HI-TORQUE FLEX-T GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1986-09-11
K863303 MODEL 617D Quinton, Inc. LDD Class II 1986-09-05
K862567 ACS WIRE SHAPER Advanced Cardiovascular Systems, Inc. DQX Class II 1986-09-04
K862974 ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. Medtronic Vascular DXY Class III 1986-09-04
K862609 INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 Medical, Inc. DTM Class II 1986-09-04
K862591 INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 Medical, Inc. DTM Class II 1986-09-04
K862547 MECHANICAL INFLATION DEVICE American Edwards Laboratories DXT Class II 1986-09-03
K860749 HA-2 HUMAN BODY COMPOSITION ANALYZER Dj Medical Instrument Corp. C/O Keller & Heckman DSB Class II 1986-09-02
K862550 OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE Meadox Surgimed, Inc. LIT Class II 1986-09-02
K862466 SCHNEIDER-SHILEY FLUSHING CATHETER Shiley, Inc. DQO Class II 1986-08-29
K862540 LEFT VENTRICULAR VENT VALVE MODEL NO. GLV Gish Biomedical, Inc. DWD Class II 1986-08-29
K862119 DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR Parke-Davis Co. DYG Class II 1986-08-29
K861493 OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH Oscor Medical Corp. DTB Class III 1986-08-28
K862798 MINIOX 100 PULSE OXIMETER Catalyst Research Corp. DQA Class II 1986-08-28
K854790 CERYX PACEMAKER MODELS 114, 314 & 614 Vitatron Medical BV DXY Class III 1986-08-28
K861851 SIEMENS-ELEMA (SICARD-P) Mortara Instrument, Inc. DPS Class II 1986-08-28
K861850 BURDICK DIVISION (E-500) Mortara Instrument, Inc. DPS Class II 1986-08-28
K862464 SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR Shiley, Inc. DQO Class II 1986-08-28
K862953 CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE Classic Medical Products, Inc. DRY Class II 1986-08-25
K860488 OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915 Cas Medical Systems, Inc. DXN Class II 1986-08-25
K862056 [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP Arrow Intl., Inc. DQY Class II 1986-08-25
K862526 MINI-HOLTER, MODEL 2000 Holter Recorders DSH Class II 1986-08-25
K862748 MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION Cambridge Medical Instruments, Inc. DPS Class II 1986-08-25
K860973 CIRCADIAN STRESS TEST SYSTEM Circadian, Inc. DPS Class II 1986-08-25
K862244 MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS Cordis Corp. DQO Class II 1986-08-25
K861504 MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR Fukuda Denshi USA, Inc. DXN Class II 1986-08-25
K861981 ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR Vital Signs, Inc. DRW Class II 1986-08-25
K862739 INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES Intervascular, Inc. DSY Class II 1986-08-21
K862357 MODIFIED CARDIOTOMY RESERVOIR 5M1470 3M Health Care, Sarns DTN Class II 1986-08-19
K862288 MODIFICATION OF TISSUE DILATOR Quinton, Inc. DRE Class II 1986-08-19
K860462 SEAMED MODEL 3000 Seamed Corp. DTC Class II 1986-08-19
K861092 MODEL SP1465 CARDIAC OUTPUT COMPUTER Gould, Inc. DXG Class II 1986-08-18
K854845 INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR Intervascular, Inc. DSY Class II 1986-08-18
K862776 SPECTRUM POLYCORD I RECORDER SYSTEM Cardionics, Inc. DSH Class II 1986-08-18
K862161 OSC-80 OXIMETER Waters Instruments, Inc. DQA Class II 1986-08-18
K862647 PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 Ivy Biomedical Systems, Inc. DSK Class II 1986-08-18
K860473 DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE Schering Corp. LDE Class I 1986-08-14
K855127 AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202 Spacelabs, Inc. DXN Class II 1986-08-14
K862465 SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK Shiley, Inc. DQO Class II 1986-08-11
K862467 SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR Shiley, Inc. LIT Class II 1986-08-11
K862030 POLY-TECH ANGIOGRAPHY CATHETER Poly-Tech Medical Device Research & Development DQO Class II 1986-08-08
K860921 NEOS VS-1, PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1986-08-08
K862068 GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) Gelman Sciences, Inc. DTM Class II 1986-08-08
K862330 MODIFIED OSCOR PY PACING LEADS Oscor Medical Corp. DTB Class III 1986-08-08
K861246 PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD Conmedcorp DRX Class II 1986-08-06
K861375 MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS Sharp Electronics Corp. DXN Class II 1986-08-06
K862544 KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH Suzuken Co., Ltd. DPS Class II 1986-08-06
K861099 GEREONICS BIOPOTENTIAL SKIN ELECTRODES Gereonics, Inc. DRX Class II 1986-08-06
K862344 GOULD XCALIBER Bio-Tek Instruments, Inc. DRS Class II 1986-08-06
K862765 EUROMED S-601 Lectec Corp. DRX Class II 1986-08-06
K862756 PREGELLED INFANT DISPOSABLE ECG ELECTRODE Labeltape Meditect, Inc. DXN Class II 1986-08-06
K861364 NEOGUARD ECG ELECTRODES Cas Medical Systems, Inc. DXN Class II 1986-08-06
K862655 SIGNA II RESTING ECG ELECTRODE Kone Instruments, Inc. DRX Class II 1986-08-06
K862746 EM DIAGNOSTIC ECG ELECTRODE Electromed Intl., Ltd. DRX Class II 1986-08-06
K861984 UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO Universal Medical Instrument Corp. DYB Class II 1986-08-05
K851064 CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR Cordis Corp. DTB Class III 1986-08-05
K832422 CORDIS ANCOR ACTIVE FIXATION LEAD Cordis Corp. DTB Class III 1986-08-05
K860922 MIKROS, MIKROS VS-1, PULSE GENERATOR Biotronik Sales, Inc. DXY Class III 1986-08-04
K861368 MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR Medtronic Vascular JOQ Class II 1986-08-04
K861281 MICROCOR E.C.G. MONITOR WITH A.C. ADAPTER Microcor, Inc. DPS Class II 1986-08-01
K860689 SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE Spacelabs, Inc. DSK Class II 1986-07-30
K861579 ACUSON L558 TRANSDUCER Acuson Computed Sonography JOP Class II 1986-07-30
K861596 ACUSON S519 TRANSDUCER Acuson Computed Sonography JOP Class II 1986-07-30
K862656 PACEMAKER LEAD ADAPTER Cordis Corp. DTD Class II 1986-07-30
K860766 MILLAR PULSED DOPPLER VELOCIMETER Millar Instruments, Inc. DPW Class II 1986-07-29
K862159 ACUSON S319 TRANSDUCER Acuson Computed Sonography JOP Class II 1986-07-24
K861737 MERIDIAN IMAGING SYSTEM Johnson & Johnson Professionals, Inc. JOP Class II 1986-07-24
K861790 RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT Research Medical, Inc. DWF Class II 1986-07-21
K861866 ACUSON L382 AND L312 TRANSDUCERS Acuson Computed Sonography JOP Class II 1986-07-18
K861767 IMPLANTABLE ELECTRODE LEAD, MODEL 030-436 Telectronics, Inc. DTB Class III 1986-07-18
K862069 CARDIOMET 4000 GAS MONITORING SYSTEMS Biomedical Sensors, Inc. DRY Class II 1986-07-18
K860430 THE NAVIGATOR STEERABLE GUIDE WIRE Meadox Surgimed, Inc. DQX Class II 1986-07-18
K861860 COBE ACCESSORY INTERFACE MODULE (AIM) Cobe Laboratories, Inc. KRL Class II 1986-07-18
K860651 MICRON, MICROVASCULAR DOPPLER Diagnostic Electronics Corp. DPW Class II 1986-07-18
K862510 STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 Shiley, Inc. KRI Class I 1986-07-17
K861783 DISPOSABLE STOPCOCK Utah Medical Products, Inc. DTL Class II 1986-07-17
K862381 FUTUREMED ECG SYSTEM 500 Futuremed Div. of Future Impex Corp. DPS Class II 1986-07-17
K854910 ANGIOFLOW Angiomed U.S., Inc. DQO Class II 1986-07-17
K861714 STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE Shiley, Inc. DWB Class II 1986-07-16
K861238 ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV Angiomedics, Inc. DYB Class II 1986-07-16
K860585 ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR Cardiac Pacemakers, Inc. DXY Class III 1986-07-16
K862116 STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE Shiley, Inc. DWB Class II 1986-07-16
K855096 SIEMENS SIRECUST MODELS 403P,403-2P & 403N Analogic Corp. DPS Class II 1986-07-15
K853771 PINNACLE MULTI-PROGRAMMABLE PACING SYS Cardio-Pace Medical, Inc. DXY Class III 1986-07-15
K862549 ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE American Bentley KRI Class I 1986-07-15
K861827 CURITY CENTRAL VENOUS CATHETERIZATION TRAY The Kendal Co. DQY Class II 1986-07-11
K861115 TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE Toray Industries (America), Inc. DQX Class II 1986-07-11

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