meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
1988-05-02

Clearances · page 149 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K880776 7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM Medsurg Industries, Inc. DQR Class II 1988-05-02
K873012 INFANT CANNULA Gresco International, Inc. DQR Class II 1988-05-02
K880661 FIBEROPTIC CATHETER Optimed Technologies, Inc. DQO Class II 1988-05-02
K875266 SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM Toshiba Medical Systems DPT Class II 1988-04-29
K880493 MEDRAD MICROPROCESSOR CT INJECTION SYSTEM Medrad, Inc. DXT Class II 1988-04-28
K880421 DESCENDING ARCH CANNULA Dlp, Inc. DWF Class II 1988-04-28
K880451 SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS Scimed Life Systems, Inc. DTR Class II 1988-04-28
K874202 ACS HI-TORQUE GUIDE WIRES Advanced Cardiovascular Systems, Inc. DQX Class II 1988-04-28
K880217 SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN. Ge Medical Systems Information Technologies DXK Class II 1988-04-25
K870878 EUB-305 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America DXK Class II 1988-04-22
K880310 ANGIO DRAPE PACK ACP-010FM Arrow Intl., Inc. DXT Class II 1988-04-22
K880298 PERIPHERAL DILATATION CATHETER Medi-Tech, Inc. LIT Class II 1988-04-22
K872520 SS-1000 POLYGRAPH Meramed Corp. DQA Class II 1988-04-19
K880194 KENSEY CATHETER Theratek, Inc. LIT Class II 1988-04-18
K880326 MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS Cardiac Control Systems, Inc. DXY Class III 1988-04-11
K880626 KING OF HEARTS Instromedix, Inc. DXH Class II 1988-04-11
K881085 SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE Contour Electrodes, Inc. DRX Class II 1988-04-11
K874816 KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000 Kontron Instruments, Inc. DSP Class II 1988-04-01
K874641 CIRCADIAN STRESS TEST II Circadian, Inc. DPS Class II 1988-04-01
K880052 EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR Baxter Healthcare Corp DTJ Class I 1988-04-01
K873972 GUIDE WIRE INTRODUCER Target Therapeutics DQX Class II 1988-04-01
K880021 COBE CML3 Cobe Laboratories, Inc. DTZ Class II 1988-04-01
K880422 MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER Cardiac Control Systems, Inc. DXY Class III 1988-03-31
K880079 TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420 A&D Engineering, Inc. DSK Class II 1988-03-31
K874726 MASCOT STETHOSCOPE PROBE Imex Medical Systems, Inc. DQD Class II 1988-03-31
K875322 MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER Schneider-Shilley (Usa) KRK Class II 1988-03-28
K875323 MODIFIED SCHNEIDER-SHILEY WIRE TORQUER Schneider-Shilley (Usa) DQX Class II 1988-03-28
K875324 MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES Schneider-Shilley (Usa) DXT Class II 1988-03-25
K875327 MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT Schneider-Shilley (Usa) DRE Class II 1988-03-25
K873410 DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE Blood Gas Supply Co. DXT Class II 1988-03-25
K880158 ANGIOPLASTY BALLOON INFLATION DEVICE L.O.N. Research, Inc. LIT Class II 1988-03-22
K875057 FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR Fukuda Denshi USA, Inc. DPS Class II 1988-03-22
K880180 STATFLO Imodex, Inc. DWF Class II 1988-03-22
K873403 CORDIS STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1988-03-22
K880740 MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE Spectramed, Inc. DQF Class II 1988-03-22
K872126 MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD Intermedics, Inc. DTB Class III 1988-03-22
K880320 ELECTRODE CABLE Vital Connections, Inc. DSA Class II 1988-03-22
K880351 VITAL SYSTEM Pace Tech, Inc. DXN Class II 1988-03-22
K874233 BLOOD PRESSURE SLEEVE W/TUBING Devcom, Inc. DXQ Class II 1988-03-22
K880323 MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR Medtronic Vascular DSA Class II 1988-03-22
K874492 LAWRENCE L4000 REFLECTANCE PULSE OXIMETER Lawrence Medical Systems, Inc. DQA Class II 1988-03-22
K880103 CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL. Research Medical, Inc. DWF Class II 1988-03-22
K874198 VITALOG HMS-3000 Vitalog Corp. DQA Class II 1988-03-22
K880066 MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR Ivy Biomedical Systems, Inc. DRT Class II 1988-03-22
K875353 PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT Dlp, Inc. DWF Class II 1988-03-22
K874361 BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER Biodynamics Corp. DSB Class II 1988-03-16
K880283 PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS Paceart, Inc. DXH Class II 1988-03-09
K880664 MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED) Mortara Instrument, Inc. DSI Class II 1988-03-09
K874319 MONITOR, ELECTROGRAPHIC Medac, Inc. DRT Class II 1988-03-07
K874542 TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES Toray Industries (America), Inc. DQX Class II 1988-03-07
K875298 502-US PULSE OXIMETER Criticare Systems, Inc. DQA Class II 1988-03-07
K880036 BIOMA 5000 E.B.S., Inc. DRG Class II 1988-03-07
K880551 MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD Intermedics, Inc. DTB Class III 1988-03-07
K873896 SIMED S-100 PULSE OXIMETER Simed DQA Class II 1988-03-07
K871555 RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA. General Electric Co. DXK Class II 1988-03-02
K873989 DOPPLEX ULTRASONIC DOPPLER SYSTEM Ultramed, Inc. JOP Class II 1988-03-02
K870816 KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM Kontron Instruments, Inc. DSI Class II 1988-03-01
K875094 ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE Pall Biomedical Products Co. KRJ Class II 1988-02-29
K875095 PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE Pall Biomedical Products Co. JOD Class II 1988-02-29
K875080 AIR VENT LINE CAT. NO. AVL-36 American Omni Medical, Inc. DTM Class II 1988-02-29
K875016 BIOSURGE MODEL ILVC-1 Biosurge, Inc. DWS Class I 1988-02-29
K875090 AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP* United States Surgical, A Division of Tyco Healthc DXC Class II 1988-02-29
K875265 NON-INVASIVE BLOOD PRESSURE MODULE Ppg Industries, Inc. DXN Class II 1988-02-29
K873100 OLYMPUS ANGIOSCOPY SHEATH Olympus Corp. DYB Class II 1988-02-29
K875064 SCIMED INFLATION DEVICE, MODEL SM 2000 Scimed Life Systems, Inc. LIT Class II 1988-02-29
K873673 BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL Sonicaid, Inc. DPT Class II 1988-02-26
K871572 RHYTHMSCAN Brentwood Instruments, Inc. DSI Class II 1988-02-22
K880432 VICOR PACER, MODEL 410A Tpl-Cordis, Inc. DXY Class III 1988-02-22
K874313 MODEL 492 SSR (TM) RECORDER Del Mar Avionics DSH Class II 1988-02-22
K872441 HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR Advanced Technology Laboratories, Inc. DPT Class II 1988-02-19
K874874 ACS HI-TORQUE CORONARY GUIDING CATHETER W/SOFT TIP Advanced Cardiovascular Systems, Inc. DQY Class II 1988-02-18
K873032 GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN Biosound, Inc. DXK Class II 1988-02-18
K875048 SARNS VENOATRIAL CATHETER 3M Health Care, Sarns DWF Class II 1988-02-18
K875326 MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER Schneider-Shilley (Usa) DQO Class II 1988-02-18
K873762 SERIES 77000 ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. DXK Class II 1988-02-18
K875325 MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK Schneider-Shilley (Usa) DQO Class II 1988-02-18
K875272 SONOLINE CF Siemens Medical Laboratories, Inc. DXK Class II 1988-02-18
K875199 NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR Biotronik Sales, Inc. DTB Class III 1988-02-18
K874442 DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER Critikon Company, LLC DQA Class II 1988-02-18
K874899 CANYON MEDICAL FEMORAL BYPASS CANNULAE Canyon Medical Products DWF Class II 1988-02-18
K871912 PV-LAB, MODEL PVL-1, PERIPHERAL VASCULAR SYSTEM Electro-Diagnostic Instruments DPT Class II 1988-02-18
K874776 ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR Advanced Cardiovascular Systems, Inc. DQX Class II 1988-02-17
K875269 ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE Advanced Cardiovascular Systems, Inc. DQY Class II 1988-02-12
K874751 TRACKER-25 INFUSION CATHETER Target Therapeutics DQY Class II 1988-02-12
K872971 PERMANENT MYOCARDIAL LEADS MP SERIES Oscor Medical Corp. DTB Class III 1988-02-12
K874947 MODEL 8800 CARDIORESPIRATORY OXIMETER Nonin Medical, Inc. DQA Class II 1988-02-12
K875031 OXYGEN/PULSE MONITOR Healthdyne, Inc. DQA Class II 1988-02-12
K875059 DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE Daig Corp. LDF Class II 1988-02-12
K875196 DISPOSABLE CORONARY CONTROL SYRINGE 12CC Merit Medical Systems, Inc. DXT Class II 1988-02-11
K874844 CARE TELSTAT MODELS: MP 5010 AND MP 5020 Care Systems, Inc. DRT Class II 1988-02-09
K874774 TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS Vinyl Technology, Inc. LHX Class II 1988-02-08
K874853 POLYSTAN TWO STAGE CATHETERS Polystan C/O Vitalcor, Inc. DWF Class II 1988-02-05
K873173 MEDRAD MRI INJECTION SYSTEM Medrad, Inc. DXT Class II 1988-02-05
K874815 TARGET THERAPEUTICS STERILE PRODUCTS Target Therapeutics DQO Class II 1988-02-05
K874885 LAWRENCE L3000 CARDIAC OUTPUT MONITOR Lawrence Medical Systems, Inc. DPW Class II 1988-02-05
K874338 TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610 A&D Engineering, Inc. DSK Class II 1988-02-05
K874171 MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM Hewlett-Packard Co. DQK Class II 1988-02-05
K875093 NEW MODEL MB-550 BLOOD PRESSURE MONITOR Sharp Electronics Corp. DXN Class II 1988-02-05
K874852 POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS Polystan C/O Vitalcor, Inc. DWF Class II 1988-02-05
K870884 RADIALLY-SUPPORTED VASCULAR PROSTHESES Intervascular, Inc. DSY Class II 1988-02-05

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