meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
1988-02-05

Clearances · page 150 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K873955 NAMIC ANGIOGRAPHIC SYRINGE North American Instrument Corp. DXT Class II 1988-02-05
K874960 CARDIOVASCULAR SURGICAL INSTRUMENTS Solway, Inc. DWS Class I 1988-02-05
K873041 A-V RECORDER Life Sciences Manufacturing, Inc. DPT Class II 1988-02-04
K874939 SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED Kirschner Medical Corp. DXQ Class II 1988-02-02
K874205 ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T Pacesetter Systems DTB Class III 1988-02-02
K874841 INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER Bentley Laboratories, Inc. DTZ Class II 1988-02-02
K873924 PTI HEART-CHILL POUCH/PAD SLING (STERILE) Buckman Co., Inc. DWC Class II 1988-02-02
K873962 MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD Medtronic Vascular DTB Class III 1988-02-02
K874692 PULSEMATE BX-5 Colin Medical Instruments Corp. DQA Class II 1988-02-02
K873199 OHMEDA 4700 OXICAP MONITOR Ohmeda Medical DQA Class II 1988-02-02
K874605 HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR Mallinckrodt Critical Care KRI Class I 1988-02-02
K874896 SARNS VISIFLOW AORTIC ARCH CANNULA 3M Health Care, Sarns DWF Class II 1988-02-02
K874037 ANGIO WASTE FLUIDS DUMP BAG Procedure Products, Inc. DQO Class II 1988-01-29
K873546 VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM Reimers Engineering, Inc. DWJ Class II 1988-01-29
K874183 ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD Daig Corp. DTB Class III 1988-01-29
K874695 HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 Healthdyne, Inc. DRT Class II 1988-01-29
K874571 PATIENTWATCH (TM) Advanced Medical Technology, Inc. DSH Class II 1988-01-29
K874522 MODIFIED MYOCARDIAL TEMPERATURE SENSOR Mon-A-Therm, Inc. KRB Class II 1988-01-29
K873533 SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE Medical Electronics Laboratories, Inc. DSI Class II 1988-01-29
K874927 PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET Pioneering Technologies, Inc. DWC Class II 1988-01-29
K874562 SECURATRODE Meddev International Corp. DRX Class II 1988-01-28
K874423 PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E Hewlett-Packard Co. DRX Class II 1988-01-28
K874421 PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A Hewlett-Packard Co. DRX Class II 1988-01-28
K875041 FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE Labeltape Meditect, Inc. DRX Class II 1988-01-28
K875015 TRACETS 3000 Lectec Corp. DRX Class II 1988-01-28
K874424 PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E Hewlett-Packard Co. DRX Class II 1988-01-28
K874422 PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D Hewlett-Packard Co. DRX Class II 1988-01-28
K872866 STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE) Labeltape Meditect, Inc. DRX Class II 1988-01-28
K874204 450SLL DEFIBRILLATOR Medical Research Laboratories, Inc. LDD Class II 1988-01-28
K875147 TORQUE HEX WRENCH Cardiac Pacemakers, Inc. DTF Class I 1988-01-27
K874447 DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC Medac, Inc. DRO Class II 1988-01-27
K871850 TELEFLEX STEERABLE GUIDEWIRE Teleflexmedical, Inc. DQX Class II 1988-01-27
K874132 MINIOX IV PORTABLE PULSE OXIMETER Catalyst Research Corp. DQA Class II 1988-01-19
K874441 BARD BIOPOTENTIAL AMPLIFIER C.R. Bard, Inc. DRR Class II 1988-01-19
K874924 CAP-35 AND CAP35 F Gish Biomedical, Inc. DTP Class II 1988-01-19
K874834 ARGYLE CARDIOPLEGIA CANNULA Sherwood Medical Co. DWF Class II 1988-01-19
K874792 MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD Medtronic Vascular DTB Class III 1988-01-19
K874618 BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER Bentley Laboratories, Inc. DQR Class II 1988-01-19
K873971 ROTATING HEMOSTATIC VALVE Target Therapeutics DTL Class II 1988-01-19
K874925 CPE 2000 CARDIO PULMONARY ERGOMETER Medical Graphics Corp. KRI Class I 1988-01-19
K874743 PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390 Pace Medical DTB Class III 1988-01-19
K874771 ANGIOMED INTRODUCING SETS Angiomed U.S., Inc. DWB Class II 1988-01-12
K873168 SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS Spectramed, Inc. DRS Class II 1988-01-12
K873158 MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS Tpl-Cordis, Inc. DXY Class III 1988-01-07
K873874 CARDIOFAX-V ECG-8110A Nihon Kohden America, Inc. DSI Class II 1988-01-07
K874531 POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD Intermedics, Inc. DTB Class III 1988-01-07
K873995 BARD DESAI CATHETER ELECTRODE C.R. Bard, Inc. DRF Class II 1988-01-07
K872658 MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH Del Mar Avionics DPS Class II 1988-01-06
K874930 MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER Intermedics, Inc. DTB Class III 1988-01-06
K872928 LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH Fidelity Medical, Inc. DQK Class II 1988-01-06
K874706 MODIFIED SIMPSON PERIPHERAL ATHEROCATH Devices For Vascular Intervention, Inc. LIT Class II 1988-01-04
K874378 DINAMAP VITAL SIGNS MONITOR, MODEL 8100T Critikon Company, LLC DXN Class II 1987-12-30
K874437 TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE) Labeltape Meditect, Inc. DRX Class II 1987-12-30
K874405 PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE Pall Biomedical Products Co. JOD Class II 1987-12-30
K874208 BARD OCTAPOLAR ELECTRODE CATHETER C.R. Bard, Inc. DRF Class II 1987-12-29
K872781 EASI LEAD SYSTEM CABLE ASSEMBLY Totemite Medical Electronics DRW Class II 1987-12-29
K871751 QUIK-PACE NONINVASIVE PACEMAKER Physio-Control Corp. DRO Class II 1987-12-29
K874158 CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. Cardiac Control Systems, Inc. DXY Class III 1987-12-29
K873682 FERRIS ECG ELECTRODE W/HYDROGEL Ferris Mfg. Corp. DRX Class II 1987-12-29
K873859 CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104 Datex Division Instrumentarium Corp. DQA Class II 1987-12-29
K873942 GUIDE WIRE BOWL Condor Medical DQX Class II 1987-12-23
K874310 WIRE DRESSING Slocum and Neal, Inc. LDF Class II 1987-12-23
K873699 ECMO-TEMP (TM) BLOOD WARMING DEVICE Seabrook Medical Systems, Inc. DWC Class II 1987-12-22
K874768 FUKUDA DENSHI MODEL FCP-231 Fukuda Denshi USA, Inc. DSI Class II 1987-12-18
K874339 TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620 A&D Engineering, Inc. DSK Class II 1987-12-18
K874387 PCI MODEL RS100 TELEMETRY MONITOR Accucore, Inc. DXH Class II 1987-12-18
K864712 MODEL 1740 PERSONAL POCKET PROGRAMMER Telectronics, Inc. KRG Class III 1987-12-17
K873195 SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO Angiomedics, Inc. DYB Class II 1987-12-15
K874697 STRATUM D Alternative Design Systems, Inc. LDD Class II 1987-12-15
K865017 ANGIOSCOPE Mansfield Scientific, Inc. DQX Class II 1987-12-15
K873997 ANTI-SHOCK TROUSERS Simulaids, Inc. JOW Class II 1987-12-15
K872548 FITNESS RECUMBENT ERGOMETER, MODEL FT1400 Invacare Corp. DPS Class II 1987-12-15
K874090 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER Medac, Inc. DRO Class II 1987-12-15
K872033 BIO-MEDICUS CANNULA-TUBING Bio Medicus, Inc. DWF Class II 1987-12-07
K874628 RESUBMITTED STANDARD MICROPORE ECG ELECTRODE Labeltape Meditect, Inc. DRX Class II 1987-12-07
K871490 COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION Ge Medical Systems Information Technologies DPW Class II 1987-12-07
K872370 BIOMA 3500 E.B.S., Inc. KRC Class II 1987-12-07
K874167 MEDTRONIC PERMANENT LEAD INTRODUCER Medtronic Vascular DTB Class III 1987-12-07
K873640 MODIFIED DSP100 AMPLIFIER Intl. Acoustics, Inc. DQC Class I 1987-12-07
K874242 JEHLE CORONARY PERFUSION CATHETERS Pilling Co. KRA Class II 1987-12-07
K873485 EDSLAB (R) OCCLUSION BALLOON CATHETER American Edwards Laboratories DQY Class II 1987-12-03
K873672 MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR Novametrix Medical Systems, Inc. DRG Class II 1987-12-03
K872972 TEMPORARY PACEMAKER ELECTRODE Oscor Medical Corp. LDF Class II 1987-12-03
K871796 NUMED PTA CATHETERS NuMED, Inc. LIT Class II 1987-12-03
K874104 OHMEDA BIOX 3760 PULSE OXIMETER Ohmeda Medical DQA Class II 1987-12-03
K870700 MICRO-GUIDE Catheter Research C/O Burditt, Bowles & Radzius DQO Class II 1987-12-03
K873921 MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE Intermedics, Inc. DTB Class III 1987-12-03
K873543 STUBBIE STEERABLE GUIDEWIRE Target Therapeutics DQX Class II 1987-12-03
K871517 OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE Olympus Corp. DQX Class II 1987-11-30
K873438 USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER C.R. Bard, Inc. DQO Class II 1987-11-27
K864257 TELEPHONE DEFIBRILLATOR SYSTEM Medphone Corp. LDD Class II 1987-11-27
K873979 DYNAMARK 1000 Dynamedics, Inc. DXN Class II 1987-11-27
K873402 ZOLL NTP-1200 PACER/DEFIBRILLATOR Zmi Corp. DRO Class II 1987-11-23
K874394 QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. Intermedics, Inc. DXY Class III 1987-11-23
K871993 MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH Cambridge Medical Instruments, Inc. DPS Class II 1987-11-23
K874091 360D DC DEFIBRILLATOR Medac, Inc. LDD Class II 1987-11-23
K873680 MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM Oxford Medilog, Inc. DSI Class II 1987-11-23
K873442 ECG ELECTRODE SYSTEM Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S DRX Class II 1987-11-23
K874155 CIRCAMED MONITOR REMOTE START CONDUCTANCE METER Circadian, Inc. KRC Class II 1987-11-23
K874327 SKIN PREP ANALYZER Marquette Electronics, Inc. KRC Class II 1987-11-23

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