meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
44
Latest Decision
1986-03-11

Clearances · page 159 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854917 MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD Intermedics, Inc. DTB Class III 1986-03-11
K852739 SONOLINE SX ULTRASOUND SCANNER Siemens Medical Solutions USA, Inc. DXK Class II 1986-03-10
K855081 PHOENIX MODELS 250/251 PULSE GENERATORS Pacesetter Systems DXY Class III 1986-03-07
K860672 ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL American Bentley KRI Class I 1986-03-03
K854013 TRANSTELEPHONIC ECG RECORDER/TRANSMITTER & RECEIVE Medrand, Inc. DXH Class II 1986-02-28
K854369 WEP 7604 TELEMETRY MONITOR Nihon Kohden America, Inc. DXH Class II 1986-02-28
K853993 DOBE (MODIFIED) Phoenix Medical Technology, Inc. DRX Class II 1986-02-28
K854372 VM 781 SLAVE SCOPE Nihon Kohden America, Inc. DXJ Class II 1986-02-28
K854482 ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS Medtronic Vascular DXY Class III 1986-02-28
K853757 MOLDTEC STIMULATOR Moldtec, Inc. DRT Class II 1986-02-28
K852829 CARDISUNY 501 A Atrix DPS Class II 1986-02-26
K854500 HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER - Medpacific Corp. DPW Class II 1986-02-26
K855049 MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR Scimed Life Systems, Inc. DTP Class II 1986-02-26
K854576 MODIFIED CORDIS PTCA GUIDING CATHETERS Cordis Corp. DQO Class II 1986-02-26
K855067 SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 Cobe Laboratories, Inc. JOD Class II 1986-02-26
K855145 MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR Gould, Inc. DRS Class II 1986-02-26
K860079 MEDILOG 4500 SYSTEM Oxford Medilog, Inc. DSI Class II 1986-02-26
K860181 MODEL MR-30 HOLTER RECORDER Oxford Medilog, Inc. DSH Class II 1986-02-26
K851241 GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO Cook, Inc. DQY Class II 1986-02-26
K854128 OSCOR MEDICAL UNIPOLAR PERMANENT PACING LEAD-CONNE Oscor Medical Corp. DTB Class III 1986-02-26
K852421 SENTRY II NONINDWELLING BLOOD PRESSURE MONITOR Nbs Medical, Inc. DXN Class II 1986-02-26
K855139 FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT Davis & Geck, Inc. LDF Class II 1986-02-26
K860078 MEDILOG 2500 SYSTEM Oxford Medilog, Inc. DSI Class II 1986-02-26
K855066 SWANK ARTERIAL LINE BLOOD FILTER HF6000 Cobe Laboratories, Inc. DTM Class II 1986-02-26
K855126 CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES Cordis Corp. DYB Class II 1986-02-26
K860182 MODEL MR-35 HOLTER RECORDER Oxford Medilog, Inc. DSH Class II 1986-02-26
K854924 AMI E-Z-PACE ELECTODE A.M.I. Corp. DRO Class II 1986-02-26
K853400 CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK Cardiac Control Systems, Inc. DXY Class III 1986-02-24
K860466 MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. Cook Pacemaker Corp. DXY Class III 1986-02-24
K860202 MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. Cook Pacemaker Corp. DXY Class III 1986-02-24
K853471 CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA Cardiac Control Systems, Inc. DXY Class III 1986-02-24
K853101 VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES Cobe Laboratories, Inc. DSY Class II 1986-02-24
K853240 MERIDIAN ULTRASOUND IMAGING SYSTEM Johnson & Johnson Professionals, Inc. JOP Class II 1986-02-21
K854606 SONOLAYER S, SSH-65A Toshiba Medical Systems DXK Class II 1986-02-20
K850861 ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE Medical Components, Inc. DXT Class II 1986-02-18
K855103 CIRIBART GYUDUBG CATGETER Mansfield Scientific, Inc. DQO Class II 1986-02-18
K855089 PERCUTANEOUS GUIDEWIRE PLACEMENT SYRINGE 50505 Dlp, Inc. DQX Class II 1986-02-18
K854853 NI-PACER 1 Associated Medical Devices, Inc. DRO Class II 1986-02-14
K855004 SWELL-RELIEF D.A. Schulman, Inc. DRM Class II 1986-02-12
K854997 IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY Telectronics, Inc. DTD Class II 1986-02-12
K855094 FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA Fukuda Denshi USA, Inc. DSI Class II 1986-02-12
K855055 PDS 9000 PATIENT DATA MGMT. SYSTEM Marquette Electronics, Inc. DQK Class II 1986-02-12
K854841 SHILEY VENOUS RESERVOIR Shiley, Inc. DTN Class II 1986-02-10
K854960 DISPOSABLE MANIFOLD Utah Medical Products, Inc. DTL Class II 1986-02-10
K854487 VENOUS RETURN CANNULA W/CUFF 91039 Dlp, Inc. DWF Class II 1986-02-10
K854734 MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE Medasonics, Inc. DRM Class II 1986-02-10
K854640 MODIFIED CORONARY CARDIOPLEGIA ADAPTOR Shiley, Inc. DWF Class II 1986-02-10
K854511 ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET Electro-Catheter Corp. DQX Class II 1986-02-10
K853979 CARDIMAX FX-1164 Brentwood Instruments, Inc. DPS Class II 1986-02-06
K854505 CARDIMAX FX-406U Brentwood Instruments, Inc. DRS Class II 1986-02-04
K854115 CUSTO PORT 24-H ECG AMBULATORY RECORDER Versacor, Inc. DSI Class II 1986-01-27
K853096 CMS 8000 Physio-Control Corp. DXH Class II 1986-01-22
K855171 TELEMETRY WAND MODEL Cardiac Pacemakers, Inc. DXY Class III 1986-01-22
K851623 MODEL TRC-40 TELEMETRY RECIEVER MODULE Eaton Medical Group DXH Class II 1986-01-22
K853062 INTRA-AORTIC BALLOON PUMP MODEL K2000 Kontron Instruments, Inc. DSP Class II 1986-01-22
K854234 ESCORT ECG MONITOR SIEMENS SIRECUST 466 Medical Data Electronics DPS Class II 1986-01-21
K853652 BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT Fisher Imaging Corp. DRR Class II 1986-01-16
K854018 ANGIOGRAPHY CATHETERS Micor, Inc. DQO Class II 1986-01-16
K854648 SEAMED MODEL 4000 Seamed Corp. DTE Class II 1986-01-16
K854560 IMPLANTABLE PROGRAMMABLE PULSE GENERATOR Telectronics, Inc. DXY Class III 1986-01-16
K853182 DIAGNOSTIC INTRAVASCULAR CATHETERS Mallinckrodt Critical Care DQO Class II 1986-01-15
K853568 DNR UNIPOLAR Biotronik Sales, Inc. DTB Class III 1986-01-15
K853625 NOVA ARTERIAL EMBOLECTOMY CATHETER Nova Medical Specialties DXE Class II 1986-01-15
K854293 MEDSURG POTT-COURNAND NEEDLE Medsurg Industries, Inc. DRC Class II 1986-01-15
K854975 ELECATH PULSATILE PERFUSION PUMP Electro-Catheter Corp. KFM Class II 1986-01-15
K854142 STYLET INTRODUCER FUNNEL Telectronics, Inc. DTB Class III 1986-01-15
K852978 COMFORT - CUF Dynasty Instruments, Ltd. DXN Class II 1986-01-14
K852641 ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER Sorin Biomedica, Fiat, USA, Inc. DXY Class III 1986-01-14
K851624 MODEL TT-185 TELEMETRY TRANSMITTER Eaton Medical Group DXH Class II 1986-01-14
K853331 OSM-1 OXYGEN SATURATION MONITOR Criticare Systems, Inc. JOM Class II 1986-01-14
K851968 CORDIS MULTICOR ST, MODEL 350A Cordis Corp. DXY Class III 1986-01-14
K854582 MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016 Medtronic Vascular DTB Class III 1986-01-13
K854294 MEDSURG SELDINGER NEEDLE Medsurg Industries, Inc. DRC Class II 1986-01-13
K854117 AMENDMENT LIFEPAK 8, NPN 052 Physio-Control Corp. DRO Class II 1986-01-13
K853446 POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107 Cardiac Control Systems, Inc. DTB Class III 1986-01-13
K854175 DEFIGARD 2000 Odam LDD Class II 1986-01-13
K853018 MODEL 3000 OPTICATH COMPUTER Oximetrix, Inc. DXG Class II 1986-01-13
K853714 PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA American Pharmaseal Div. Ahsc DQY Class II 1986-01-13
K853705 BOMED-EEA Bomed Medical Mfr., Ltd. DRX Class II 1986-01-13
K853749 CUSTOM CORONARY MANIFOLD KITS Procedure Products, Inc. DTL Class II 1986-01-13
K854233 CMI 3000 Cardio Management, Inc. DRO Class II 1986-01-08
K854282 PREVIEW XT Cambridge Medical Instruments, Inc. DSI Class II 1986-01-08
K854133 BIO MEDICUS BIO CONSOLE 540 Bio Medicus, Inc. DWA Class II 1986-01-08
K854113 CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH American Bentley KRI Class I 1986-01-08
K854357 GEM-6, WITH COMPONENTS Diamond Electro-Tech, Inc. DRY Class II 1986-01-08
K853747 NAVIGATOR Mainsfield Scientific, Inc. DTB Class III 1986-01-08
K854397 HEMOSTATIC SIDEARM Target Therapeutics DTL Class II 1986-01-08
K853132 EMERSON TRO/CATH TROCAR CATHETERS J. H. Emerson Co. DRC Class II 1986-01-08
K853038 DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES Bio-Detek, Inc. DRX Class II 1986-01-07
K854041 CD-100 CARDIAC MONITOR Cardio Display Corp. DRT Class II 1986-01-07
K854195 PROGRAMALITH III MODELS 238 & 239 Pacesetter Systems DXY Class III 1986-01-07
K842066 PERI-GUARD PERICARDIAL PATCH Genetic Laboratories, Inc. DXZ Class II 1985-12-30
K852458 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145 Healthteam DXN Class II 1985-12-30
K840569 EKG 501 A Bosch Hearing Instruments, Inc. DPS Class II 1985-12-30
K840571 EKG 503A Bosch Hearing Instruments, Inc. DPS Class II 1985-12-30
K852653 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 Healthteam DXN Class II 1985-12-30
K852459 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175 Healthteam DXN Class II 1985-12-30
K852457 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165 Healthteam DXN Class II 1985-12-30
K854559 MEDTRONIC PERMANENT LEAD INTRODUCER Medtronic Vascular DYB Class II 1985-12-24
K854919 BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY Cook Pacemaker Corp. DXY Class III 1985-12-19

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