meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
46
Latest Decision
1989-09-05

Clearances · page 143 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K894718 ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 Intermedics, Inc. DTD Class II 1989-09-05
K893587 OXIMETER Radiometer America, Inc. DQA Class II 1989-09-05
K893963 VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER V.S.B.B. Technologies, Inc. DSB Class II 1989-09-05
K893411 STEALTH DILATION CATHETER SYSTEM Target Therapeutics LIT Class II 1989-09-05
K892370 DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM Bio-Focus, Inc. DXH Class II 1989-08-28
K892795 PULSE TIME PRODUCTS LIMITED, PM-3 Pulse Time Products, Ltd. DRT Class II 1989-08-25
K892794 PULSE TIME PRODUCTS LIMITED, PM-2 Pulse Time Products, Ltd. DRT Class II 1989-08-25
K894055 MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS Medtronic Vascular DXY Class III 1989-08-25
K890988 MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE Pace Medical LDF Class II 1989-08-25
K893561 EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. Edentec Corp. DSF Class I 1989-08-25
K884420 HOME BLOOD PRESSURE KIT, ANEROID Yamasu Co. , Ltd. DXY Class III 1989-08-25
K884522 MODEL 5650 OPTIMATE PERSONAL PROGRAMMER Teletronics, Inc. KRG Class III 1989-08-25
K894062 ELECTRONIC BLOOD PRESSURE MONITORS Hanson Scale Co. DXN Class II 1989-08-24
K890405 USCI PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. LIT Class II 1989-08-17
K890404 USCI PROBE LINX EXTENSION WIRE C.R. Bard, Inc. DQX Class II 1989-08-17
K890152 USCI PROBING CATHETER C.R. Bard, Inc. DQY Class II 1989-08-17
K894185 OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR Telectronics Pacing Systems, Inc. DXY Class III 1989-08-17
K894268 C.A.B. RING Medi-Sharp, Inc. MAB Class II 1989-08-17
K894084 TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE Target Therapeutics DQY Class II 1989-08-17
K894670 GENERAL SURGICAL INSTRUMENTS Nopa Instruments DXC Class II 1989-08-10
K891069 USCI CORONARY INFUSION CATHETER C.R. Bard, Inc. DQY Class II 1989-08-09
K894430 MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY Daig Corp. DYB Class II 1989-08-09
K885179 INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD Baxter Healthcare Corp DYB Class II 1989-08-09
K890638 VOLUME COMPUTATION SOFTWARE PACKAGE Elscint, Inc. JOP Class II 1989-08-07
K890636 CARDIAC COMPUTATION SOFTWARE PACKAGE Elscint, Inc. JOP Class II 1989-08-07
K884183 BURRON TEFLON-COATED GUIDEWIRE Burron Medical, Inc. DQX Class II 1989-08-03
K893470 SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE Siemens Medical Electronics DQA Class II 1989-08-03
K893403 MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE Hewlett-Packard Co. LDD Class II 1989-08-03
K893683 SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM 3M Company DTL Class II 1989-08-03
K891580 INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING Boston Scientific Corp DQO Class II 1989-08-03
K893658 PERCUTANEOUS INTRODUCER Medamicus, Inc. DYB Class II 1989-08-03
K894161 ASC-950 ECG AMPLIFIER Astro-Med, Inc. DRR Class II 1989-08-03
K894234 SENSOCOR TM R-TEST 24OXL Sensocor DXG Class II 1989-08-03
K893680 SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. Cathlab Corp. DXE Class II 1989-08-01
K892707 DVM-4200 BLOOD FLOWMETER Koven and Assoc., Inc. DPW Class II 1989-07-28
K890114 IMEX RHYTHM TEK Racom, Inc. DSH Class II 1989-07-27
K894140 MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER Medtronic Vascular DXH Class II 1989-07-27
K891572 ANGIOGRAPHY CUSTOM PACKS Procedure Packs, Inc. DTL Class II 1989-07-24
K892410 FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER Baxter Healthcare Corp DXE Class II 1989-07-20
K892944 INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515 Interspec, Inc. JOP Class II 1989-07-19
K894040 IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR Medtronic Vascular DTB Class III 1989-07-14
K892804 NEWCHILL(TM) CARDIAC INSULATOR Acacia Laboratories, Inc. DWS Class I 1989-07-14
K885058 CARDIOCAP(TM) DR-104 REPORTER Datex Division Instrumentarium Corp. DSF Class I 1989-07-14
K892446 SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02 Shiley, Inc. KRD Class II 1989-07-14
K890676 DISPOSABLE TRANSDUCER MANIFOLD L.O.N. Research, Inc. DTL Class II 1989-07-14
K893425 VITATRACE Lectec Corp. DRX Class II 1989-07-14
K893436 MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT Pioneering Technologies, Inc. DWS Class I 1989-07-14
K893611 BARD PLAQUE ELECTRODE ARRAY Bard Electrophysiology DRF Class II 1989-07-14
K893232 MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM Camino Laboratories, Inc. DSK Class II 1989-07-14
K893763 MODELS 1113 AND 1114 PACEMAKER LEADS Possis Medical, Inc. DTB Class III 1989-07-14
K885175 MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS Possis Medical, Inc. DTB Class III 1989-07-14
K890876 BP-8800 BLOOD PRESSURE MONITOR Colin Medical Instruments Corp. DRT Class II 1989-06-22
K884800 ACTA GENOS ELECTROCARDIOGRAPH Parexel Intl. Corp. DPS Class II 1989-06-22
K892066 HORIZON CENTRAL STATION Mennen Medical, Inc. DRT Class II 1989-06-22
K882818 SEER Marquette Electronics, Inc. DSI Class II 1989-06-22
K885349 SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. Sonotek Corp. DXK Class II 1989-06-22
K892387 MODIFIED GELMAN ARTERIAL FILTER Gelman Sciences, Inc. DTM Class II 1989-06-22
K890292 PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE Coeur Laboratories, Inc. DXT Class II 1989-06-22
K893633 MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE Medtronic Vascular DTE Class II 1989-06-20
K890794 DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER Daig Corp. LDF Class II 1989-06-20
K892005 SHOCK ADVISORY ADAPTER FOR USE W/LIFEPAK 9 Physio-Control Corp. MKJ Class III 1989-06-20
K893245 L30-LB- INFANT LIMB BAND Contour Electrodes, Inc. DRX Class II 1989-06-20
K890828 PERIFLUX PF3 Perimed, Inc. DPW Class II 1989-06-20
K892227 EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) Edentec Corp. DSH Class II 1989-06-20
K893392 CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER Baxter Healthcare Corp DXG Class II 1989-06-20
K890807 GUIDE WIRE INTRODUCER Datascope Corp. DQX Class II 1989-06-20
K890505 USCI GREY/BLACK GUIDE WIRE C.R. Bard, Inc. DQX Class II 1989-06-20
K893243 INTRA AORTIC BALLOON Datascope Corp. DSP Class II 1989-06-20
K890018 PACEMAKER LEAD ADAPTER Ela Medical, Inc. DTB Class III 1989-06-20
K890323 MAX-1 (EXERCISE ELECTROCARDIOGRAPH) Marquette Electronics, Inc. DSI Class II 1989-06-16
K891180 TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT Ingress Technologies, Inc. DXP Class II 1989-06-15
K893707 AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT United States Surgical, A Division of Tyco Healthc DRC Class II 1989-06-15
K891906 ROBICSEK INTRACARDIAC SUCTION WAND Gish Biomedical, Inc. DTS Class II 1989-06-13
K892207 FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED Ep Technologies, Inc. DRF Class II 1989-06-12
K890198 PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350) Paramed Technology, Inc. DXN Class II 1989-06-12
K881979 RESUBMITTAL OF MI 1000C MICROIMAGER Ausonics Pty , Ltd. JOP Class II 1989-06-12
K890800 ROTATING HEMOSTATIC VALVE Datascope Corp. LIT Class II 1989-06-12
K891296 ATRAUMAX(TM) SURGICAL CLAMPS Applied Vascular Devices, Inc. DXC Class II 1989-06-07
K891908 BARD(R) TIP DEFLECTING ELECTRODE CATHETER C.R. Bard, Inc. DRF Class II 1989-06-05
K892067 MT9000 CHART RECORDER Astro-Med, Inc. DSH Class II 1989-06-05
K891905 CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE Pacesetter Systems DTB Class III 1989-06-05
K884491 MEDIZIV CENTRAL VEIN CATHETER Mediziv Medical Devices, Ltd. DQY Class II 1989-06-05
K892065 LIFEPAK 250 DEFIBRILLATOR/MONITOR Physio-Control Corp. MKJ Class III 1989-06-05
K890711 DUAL GRAPH (TM) RECORDER-MONITOR Somatics, Inc. DSF Class I 1989-06-02
K892835 E350 ELECTROCARDIOGRAPH Burdick Corp. DPS Class II 1989-06-01
K890408 ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR Bomed Medical Mfg., Ltd. DSB Class II 1989-06-01
K891687 EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE Medtronic Blood Systems, Inc. DTZ Class II 1989-05-31
K884423 HORIZON DISPLAY CONTROLLER PART # 266-200-010 Mennen Medical, Inc. DXJ Class II 1989-05-31
K890644 MEDTRONIC MODEL 5866-45 SIZING SLEEVE Medtronic Vascular DTB Class III 1989-05-31
K885256 MEDILOG EXCEL ECG ANALYSIS SYSTEM Oxford Medical, Inc. DSI Class II 1989-05-31
K890207 INTERVENTIONAL PRODUCTS - GUIDE WIRES E-Z-Em, Inc. DQX Class II 1989-05-31
K885191 MRL BLOOD PRESSURE MONITOR Medical Research Laboratories, Inc. DXN Class II 1989-05-23
K890515 PERIPHERAL ATHERECTOMY SYSTEM Intensive Technology, Inc. DWX Class II 1989-05-23
K892006 HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S Healthdyne, Inc. DRT Class II 1989-05-23
K890938 KENDALL SCD THERAPEUTIC SYSTEM Kendall Healthcare Products Co. Div.Of Tyco Health JOW Class II 1989-05-19
K890209 DISPOSABLE ANGIOGRAPHY NEEDLES E-Z-Em, Inc. DRC Class II 1989-05-19
K890206 E-Z-FLOW ANGIOGRAPHY CATHETERS E-Z-Em, Inc. DQO Class II 1989-05-19
K890208 HIGH PRESSURE CONNECTING SETS E-Z-Em, Inc. DXT Class II 1989-05-19
K884405 FORTEC MI-150 DIGITAL BLOOD PRESSURE METER Nam Tai Electronic & Electrical Products, Ltd. DXN Class II 1989-05-19
K891022 INTRODUCER FOR PTCA GUIDING CATHETERS Argon Medical Corp. DYB Class II 1989-05-19

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