meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
39
Latest Decision
1991-10-08

Clearances · page 133 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K913178 ACS VSW GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1991-10-08
K913543 THORACIC CATHETER STYLET Intl. Medical Devices , Ltd. DRB Class II 1991-10-04
K913038 SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION Spacelabs, Inc. DSH Class II 1991-10-04
K911402 MODEL #350 SHOCK-PLATE DEFIB ADAPTOR Cardiotronics, Inc. LDD Class II 1991-10-03
K911194 IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 Rjl Systems, Inc. DSB Class II 1991-09-30
K912172 SAFEWEDGE(TM) RELIEF VALVE DEVICE Sunscope Intl., Inc. KRB Class II 1991-09-27
K912920 SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER 3M Health Care, Ltd. DTZ Class II 1991-09-25
K912915 SARNS NON-FILTERED VENOUS RESERVOIR 3M Health Care, Ltd. DTP Class II 1991-09-25
K912798 AMPLANTZ AND BENTSON GUIDEWIRES Meadox Medicals, Div. Boston Scientific Corp. DQX Class II 1991-09-23
K911604 MDPHONE CELLULAR + RESCUE (DEFIB SYSTEM) Medphone Corp. LDD Class II 1991-09-23
K912833 CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY Camino Laboratories, Inc. DSK Class II 1991-09-23
K911333 RIGHT ATRIAL CATHETERS Akcess Medical Products, Inc. DQY Class II 1991-09-23
K913203 IMPLANT PACING LEAD TINED #3390, MODIFICATION Oscor Medical Corp. DTB Class III 1991-09-23
K912877 PROFUSE INFUSION SYSTEM Lake Region Mfg., Inc. DQY Class II 1991-09-23
K913204 MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION Oscor Medical Corp. DTB Class III 1991-09-23
K913158 MODIFIED OSCOR PY PACING LEADS/MODIFICATION Oscor Medical Corp. DTB Class III 1991-09-23
K913201 PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION Oscor Medical Corp. DTB Class III 1991-09-23
K913205 OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF Oscor Medical Corp. DTB Class III 1991-09-23
K910109 CARDIOSWISS CM-8 Care Systems, Inc. DSI Class II 1991-09-23
K910594 TRAC-WRIGHT SYSTEM, MODEL TW2 Dow Corning Wright DXT Class II 1991-09-23
K912911 LOW POROSITY (LP) VASCULAR PROSTHESIS Intervascular, Inc. DSY Class II 1991-09-23
K913393 IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION Oscor Medical Corp. DTB Class III 1991-09-23
K913202 IMPLANT PACING LEAD, TINED #3262, MODIFICATION Oscor Medical Corp. DTB Class III 1991-09-23
K904177 GALIX MA-6C HOLTER CASSETTE RECORDER Galix Instrumentacion Biomedica DSH Class II 1991-09-20
K912777 CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER Cordis Corp. DQY Class II 1991-09-20
K904176 GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER Galix Instrumentacion Biomedica DSH Class II 1991-09-20
K910004 FURUI SHUNT, 2-WAY AND 3-WAY Theramed, Inc. DWF Class II 1991-09-19
K912548 LEMAITRE-BOOKWALTER VESSEL DEVICES Vascutech, Inc. DWP Class II 1991-09-18
K911747 PRO-GUIDE American Interventional Technology DQY Class II 1991-09-18
K912235 MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD Intermedics, Inc. DTB Class III 1991-09-18
K910965 ECHOMARK CSI INTERFACE Catheter Sciences Co. LIT Class II 1991-09-17
K905819 MEDRAD VARIBLE INFUSION INJECTOR Medrad, Inc. DXT Class II 1991-09-16
K912644 CORDIS INFLATOR DEVICE Cordis Corp. MAV Class II 1991-09-16
K912655 MINIMAX OXYGENATION SYSTEM Medtronic Vascular DTZ Class II 1991-09-13
K911308 CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE Medical Equipment Designs, Inc. DXH Class II 1991-09-11
K912878 OPEN ENDED GUIDEWIRE Lake Region Mfg., Inc. DQX Class II 1991-09-11
K912961 MORSE VASCULAR INTRODUCER SET North American Instrument Corp. DYB Class II 1991-09-11
K912599 QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC Physio-Control Corp. DRO Class II 1991-09-11
K912709 MX 339 TWIN HEMOSTATIC Y CONNECTOR Medex, Inc. DTL Class II 1991-09-11
K912627 MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM Ppg Industries, Inc. MHX Class II 1991-09-10
K910643 CASIO BP-100 Casio, Inc. DXN Class II 1991-09-10
K912554 ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI Baxter Healthcare Corp KRH Class II 1991-09-09
K912156 SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE Schneider Intl., Ltd. DQX Class II 1991-09-06
K905506 ACCUCORE TELEMETRY, MODIFICATION S & W Medico Teknik DSI Class II 1991-09-06
K913450 HEART TECHNOLOGY ROTABLATOR WIRECLIP Heart Technology, Inc. MCW Class II 1991-09-06
K911957 ACS RX SUPPORT CATHETER Advanced Cardiovascular Systems, Inc. DQO Class II 1991-09-06
K912564 MEGA PERICARDIOCENTESIS KIT Mega Medical, Inc. DQY Class II 1991-09-05
K912530 CARDIOCAP II(TM) Datex Medical Instrumentation, Inc. DXN Class II 1991-09-05
K913016 WARMTOUCH Advanced Warming Systems, Inc. DWJ Class II 1991-09-04
K913226 MODEL #810 STEALTH-STIM ADULT STIMULATION PADS Cardiotronics, Inc. DRX Class II 1991-09-04
K912507 CPI MODEL 2215 & SEAMED MODEL 3400 Seamed Corp. DTE Class II 1991-09-03
K913364 SCIMED 7 FR. & 8 FR. Scimed Life Systems, Inc. DQO Class II 1991-08-30
K911665 ESCORT 300 SERIES Medical Data Electronics LDD Class II 1991-08-29
K910871 EDENTEC DIGITAL CHARTER MODEL 3710 Edentec Corp. DSF Class I 1991-08-29
K910870 EDENTEC MODEL 3711 DIGITAL RECORDER Edentec Corp. DRT Class II 1991-08-29
K910822 BARD PERIPHERAL BALLOON DILATATION CATHETER C.R. Bard, Inc. LIT Class II 1991-08-29
K903774 LP-PLUS Fidelity Medical, Inc. DPS Class II 1991-08-29
K901281 THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER Val-Mark Medical, Inc. DRB Class II 1991-08-28
K910609 PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP Biotronik, GmbH & Co. DTB Class III 1991-08-28
K910924 ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE Pacesetter Systems DTB Class III 1991-08-28
K897068 MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR Medtronic Vascular DTZ Class II 1991-08-28
K912450 TRACETS SME 5000 Lectec Corp. DRX Class II 1991-08-28
K911273 100 CM PERMANENT PACING LEAD MODELS Telectronics Pacing Systems, Inc. DTB Class III 1991-08-28
K911207 OXICOMPLUS Waters Instruments, Inc. DQA Class II 1991-08-26
K911051 MONARCH SYSTEM Baxter Healthcare Corp MHX Class II 1991-08-22
K911351 BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP Biochem International, Inc. DXN Class II 1991-08-22
K912317 SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH Schneider Intl., Ltd. LIT Class II 1991-08-22
K913134 MODEL 4220 Pace Medical DXY Class III 1991-08-22
K913400 MODEL SCR-1000 Accucore, Inc. DXH Class II 1991-08-21
K911789 MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT Medtronic Vascular DTP Class II 1991-08-20
K912078 SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION 3M Health Care, Sarns DTZ Class II 1991-08-20
K911257 MR-5200 FULL DISCLOSURE SYSTEM Mennen Medical, Inc. DSH Class II 1991-08-19
K913112 OPTI-PLAST 5F PTA CATHETERS Vas-Cath, Inc. LIT Class II 1991-08-16
K911166 DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 Diagnostic Ultrasound Corp. DXT Class II 1991-08-15
K910139 VER-MED A10014 RESTING EKG ELECTRODE & A10021 Vermont Medical, Inc. DRX Class II 1991-08-15
K912984 OPTI-PLAST 5F PTA CATHETERS, MODIFICATION Vas-Cath, Inc. LIT Class II 1991-08-13
K911763 LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) Vasamedics, LLC DPW Class II 1991-08-13
K912929 DASH IV Astro-Med, Inc. DSF Class I 1991-08-13
K911790 MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG Medtronic Vascular DTN Class II 1991-08-12
K911870 SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH Scimed Life Systems, Inc. LIT Class II 1991-08-12
K911142 LEAD TERMINAL PIN CAPS, VARIOUS MODELS Biotronik, GmbH & Co. DTD Class II 1991-08-09
K910528 BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS Possis Medical, Inc. DTB Class III 1991-08-09
K911876 SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 Shiley, Inc. DTN Class II 1991-08-09
K911097 PR4 Mortara Instrument, Inc. DSH Class II 1991-08-07
K911049 DIGITAL SPHYGMOIMANOMETER, MODEL UA-830 A&D Engineering, Inc. DXN Class II 1991-08-07
K911213 CUFFABLE Biomedical Dynamics, Inc. DXQ Class II 1991-08-07
K912119 DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212 A&D Engineering, Inc. DXN Class II 1991-08-07
K912118 DIGITAL SPHYGMOMANOMETER MODEL UA-833 A&D Engineering, Inc. DXN Class II 1991-08-07
K911956 ZOLL PD-1400 PACER/DEFIBRILLATOR Zmi Corp. DRO Class II 1991-07-31
K910608 PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP Biotronik, GmbH & Co. DTB Class III 1991-07-30
K912199 SOFTTOUCH(R) GUIDING CATHETER Mallinckrodt Medical DQY Class II 1991-07-30
K911302 MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT Medtronic Vascular DTD Class II 1991-07-30
K912191 SOFTOUCH(R) GUIDING CATHETER W/BUMPER TIP Mallinckrodt Medical DQY Class II 1991-07-30
K912084 MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221 Medtronic Vascular DXH Class II 1991-07-30
K912076 POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF The R Group DQO Class II 1991-07-30
K912051 MEDI-THERM (MTA-5900) & DETACHABLE HOSES Gaymar Industries, Inc. DWJ Class II 1991-07-30
K912587 K-FREE Katecho, Inc. LDD Class II 1991-07-30
K910852 507 NON-INVASIVE VITAL SIGNS MONITOR Criticare Systems, Inc. DRT Class II 1991-07-30
K912427 MULTICHANNEL RECORDING SYSTEM Bionique DSH Class II 1991-07-26
K912545 MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE Pace Medical DXY Class III 1991-07-26

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