meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
49
Latest Decision
1988-09-26

Clearances · page 147 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K883053 SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A Scimed Life Systems, Inc. DTZ Class II 1988-09-26
K883135 PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) Pioneering Technologies, Inc. DWS Class I 1988-09-26
K883332 MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 Shiley, Inc. DTR Class II 1988-09-26
K882969 VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT Gish Biomedical, Inc. DQY Class II 1988-09-26
K882427 CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 Ela Medical, Inc. DXY Class III 1988-09-23
K883103 EPICARDIA PC/FC Medicomp, Inc. DSI Class II 1988-09-22
K881488 HOLTER SCANNER Cardiodata Corp. DSI Class II 1988-09-20
K882683 JOBST EXTREMITY PUMP(R) SYSTEM 7500 Jobst Institute, Inc. JOW Class II 1988-09-20
K883031 Q-CATH RM Quinton, Inc. DXJ Class II 1988-09-20
K883121 QUIK-PACE II ELECTRODES Physio-Control Corp. DRO Class II 1988-09-20
K875179 MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A Tsi, Inc. DPW Class II 1988-09-19
K883016 POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP Cardiac Control Systems, Inc. DTB Class III 1988-09-16
K883086 INTERSEPT*PREBYPASS FILTER Medtronic Blood Systems, Inc. KRJ Class II 1988-09-16
K882803 ET HI-FLOW SOFT TIP/ET HI-FLOW/ENHANCED TORQUE ST Advanced Cardiovascular Systems, Inc. DQY Class II 1988-09-16
K881297 BARO-GRAF 24 Instromedix, Inc. DRS Class II 1988-09-16
K882716 PROCEDURE PACKS SOLUTION ADMINISTRATION SETS Procedure Packs, Inc. DQD Class II 1988-09-16
K882664 MRL OXIMETER Medical Research Laboratories, Inc. DQA Class II 1988-09-16
K882655 PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE Procedure Packs, Inc. DQO Class II 1988-09-16
K882720 SCIMED R30 SILICONE ASSIST RESERVOIR Scimed Life Systems, Inc. DTN Class II 1988-09-16
K883087 PROLOG MP 658M PULSE GENERATOR Pacesetter Systems DXY Class III 1988-09-14
K882052 OMEGA NV(TM) BALLOON DILATATION CATHETER Cook, Inc. LIT Class II 1988-09-14
K882474 OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 Ela Medical, Inc. DXY Class III 1988-09-12
K883341 HEARTSTART 1000 Laerdal Mfg. Corp. MKJ Class III 1988-09-12
K883344 HEARTSTART 1000S Laerdal Mfg. Corp. MKJ Class III 1988-09-12
K880287 TRU-TRAC COILED GUIDEWIRE N-S Medical Products DQX Class II 1988-09-12
K882476 OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 Ela Medical, Inc. DXY Class III 1988-09-12
K880288 TRU-TRAC TORQUE GUIDEWIRE N-S Medical Products DQX Class II 1988-09-12
K882879 PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) Pioneering Technologies, Inc. DXC Class II 1988-09-12
K883095 MX860, REUSABLE PRESSURE TRANSDUCER Medex, Inc. DRS Class II 1988-09-12
K881412 MYOCARD BIOPSY FORCEP Fehling Medizintechnik GmbH DWZ Class II 1988-09-08
K881893 NUMED BALLOON THERMODILUTION CATHETER NuMED, Inc. KRB Class II 1988-09-06
K883602 BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD Intermedics, Inc. DTB Class III 1988-09-06
K882330 BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER C.R. Bard, Inc. LDF Class II 1988-09-06
K882442 RK2000 K-THERMIA SYSTEM Baxter Healthcare Corp DWJ Class II 1988-09-06
K883203 MODEL 5866-34A PACEMAKER LEAD ADAPTOR Medtronic Vascular DTB Class III 1988-09-06
K882329 L-F COILED EXTENSION TUBING Mallinckrodt Group, Inc. DXT Class II 1988-09-02
K880971 DIGITAL MEDICINE ECG MONITOR AND RECORDER Digital Medicine Systems DXH Class II 1988-08-30
K882393 DIGITAL BLOOD PRESSURE MONITOR MODEL HEM-703CP Omron Electronics, Inc. DXN Class II 1988-08-30
K882321 ACS DEFLECTABLE TIP GUIDE WIRE W/MICROGLIDE(R)COAT Advanced Cardiovascular Systems, Inc. DQX Class II 1988-08-30
K882338 MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE Cardiotronics, Inc. DRO Class II 1988-08-30
K883375 MODEL #918 MULTI-PADS Cardiotronics, Inc. DRO Class II 1988-08-30
K882593 MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM Cardio Metrics, Inc. DPW Class II 1988-08-29
K882452 MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD Medtronic Vascular DTB Class III 1988-08-25
K882238 VESSEL DILATOR AND INTRODUCER SHEATH Ideal Medical, Inc. DRE Class II 1988-08-25
K882367 METATECH MICROCLIP APPLICATOR Metatech Corp. DWS Class I 1988-08-25
K882273 HORIZON 2000 PULSE OXIMETRY AND MODULE Mennen Medical, Inc. DQA Class II 1988-08-25
K880722 COATING FOR WIRE GUIDE Cook, Inc. DQX Class II 1988-08-19
K880301 3000 PHYSIOLOGICAL MONITOR Datascope Corp. DXG Class II 1988-08-19
K881055 ECG MONITOR AND RESPIRATION PACER D. E. Hokanson, Inc. DPS Class II 1988-08-19
K880761 TAPER-22 STEERABLE GUIDEWIRE Target Therapeutics DQX Class II 1988-08-19
K880762 TAPER FLEX-TIP STEERABLE GUIDEWIRE Target Therapeutics DQX Class II 1988-08-19
K882168 EXTERNAL PACEMAKER 2000 (EP2000) Unomed, Inc. DRO Class II 1988-08-19
K882137 EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 Medtronic Blood Systems, Inc. DTM Class II 1988-08-12
K882197 MINIMON 7131B PATIENT MONITOR Kontron Instruments, Inc. DPS Class II 1988-08-12
K880830 SENTORR ARTERIAL PRESSURE SENSOR Ohmeda Medical DXO Class II 1988-08-12
K882221 OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE Argon Medical Corp. DYB Class II 1988-08-12
K881723 GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER Biosound, Inc. JOP Class II 1988-08-12
K882136 INTERSEPT* OXYGEN GAS LINE FILTER Medtronic Blood Systems, Inc. KRD Class II 1988-08-11
K875127 NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS Novoste Corp. DQO Class II 1988-08-09
K882119 TELSTETH TELEMETRIC STETHOSCOPE(TM) Quantsonics, Inc. DXH Class II 1988-08-08
K882314 CORONARY VEIN GRAFT MARKER Med-Edge, Inc. DSY Class II 1988-08-04
K881897 ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW Advanced Cardiovascular Systems, Inc. DQX Class II 1988-08-03
K882337 MODEL #825 ADULT STIM. PADS POLYMER TYPE Cardiotronics, Inc. LDD Class II 1988-08-02
K882366 RHYTHMSCAN HR HOLTER RECORDER Brentwood Instruments, Inc. DSH Class II 1988-08-02
K881905 MODEL MICRO SI AMBULATORY ECG MONITOR Advanced Medical Products, Inc. DSI Class II 1988-08-02
K881475 SYSTEM5RH STATIONARY EXERCISE BICYCLE Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc. DPS Class II 1988-08-02
K880357 OMNIGRAPH 6000 Telemed Div. DPS Class II 1988-08-02
K882118 MODEL 700 PATIENT MONITOR Ivy Biomedical Systems, Inc. DRS Class II 1988-08-02
K880575 CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES Nihon Kohden America, Inc. LDD Class II 1988-08-02
K881155 MODEL BPS08 BLOOD PRESSURE MODULE Fresenius USA, Inc. DXN Class II 1988-07-28
K881884 HARBOR CENTRAL VENOUS CATHETER Harbor Medical Devices, Inc. DQR Class II 1988-07-28
K882031 VITALERT 2000 VITAL SIGNS MONITOR Draeger Medical, Inc. DXO Class II 1988-07-28
K882198 MINIMON 7132B PATIENT MONITOR Kontron Instruments, Inc. DPS Class II 1988-07-28
K881968 BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER Biodynamics Corp. DSB Class II 1988-07-28
K875175 MODIFIED PERIPHERAL DILATATION CATHETERS Schneider-Shilley (Usa) LIT Class II 1988-07-28
K880612 CORDIS PTA DILATATION CATHETERS Cordis Corp. LIT Class II 1988-07-28
K882796 SLIP-COAT(TM) CATHETERS Cook, Inc. DQO Class II 1988-07-28
K882188 MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR Ivy Biomedical Systems, Inc. DXN Class II 1988-07-28
K882097 TUNNELING STYLET Quinton, Inc. DRB Class II 1988-07-28
K880332 MEDRAD OPEN ENDED GUIDEWIRE Medrad, Inc. DQX Class II 1988-07-28
K882093 CARDIOCAP(TM) CMO-104 MONITOR Datex Division Instrumentarium Corp. DSK Class II 1988-07-28
K882034 INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER Buckman Co., Inc. DWF Class II 1988-07-28
K882035 HEART-CHILL SALINE SLUSH PAD Buckman Co., Inc. DWJ Class II 1988-07-28
K882085 PROPAQ 104(TM) Protocol Systems, Inc. DSK Class II 1988-07-28
K881153 LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR Physio-Control Corp. LDD Class II 1988-07-27
K881796 UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE Universal Medical Instrument Corp. DWS Class I 1988-07-26
K881787 ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1988-07-25
K882290 CARD GUARD, MODEL CG-2000 Card Guard Scientific Survival , Ltd. DXH Class II 1988-07-22
K881904 CHANGE TO CATHODE POWDER SPECIFICATION Telectronics and Cordis Pacing Systems DXY Class III 1988-07-22
K882429 MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 Tpl-Cordis, Inc. KRG Class III 1988-07-22
K882174 MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE Medtronic Andover Medical, Inc. DSA Class II 1988-07-22
K882216 SYNCOR (R) MODEL S-801 ECG ELECTRODE Lectec Corp. DRX Class II 1988-07-20
K881883 SATLITE+/PB251+ PULSE OXIMETER Datex Division Instrumentarium Corp. DQA Class II 1988-07-18
K882324 STETH-SHIELD ACCESSORY TO A STETHOSCOPE Steth-Shield, Inc. LDE Class I 1988-07-18
K881820 EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER Edentec Corp. DQA Class II 1988-07-18
K881837 OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D Telectronics, Inc. DXY Class III 1988-07-18
K882479 26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP Medtronic Blood Systems, Inc. DWS Class I 1988-07-18
K880936 TRIAD-EP Cardiotronics, Inc. DRO Class II 1988-07-18
K881853 FRANZ CATHETER Ep Technologies, Inc. DRF Class II 1988-07-18
K881939 SIRECUST 1280/1281 & 960/961 PATIENT MONITORS Siemens Medical Electronics DPS Class II 1988-07-18

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