meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
53
Latest Decision
1990-01-31

Clearances · page 141 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K896414 VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN Baxter Healthcare Corp DTN Class II 1990-01-31
K900272 NKA MODELS AB-601G AND AB-621G Nihon Kohden America, Inc. DPS Class II 1990-01-31
K894370 GENESIS III, (MOD. 7003/7004) Biosound, Inc. DXK Class II 1990-01-29
K895795 HPD TUBING CONNECTORS Hpd Medical, Inc. DTL Class II 1990-01-26
K882955 SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 Kontron Instruments, Inc. DXN Class II 1990-01-26
K895111 TYPE 9541 RECORDER, PAPER CHART S & W Medico Teknik DSF Class I 1990-01-26
K895533 LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER Matrix Medica, Inc. LDD Class II 1990-01-26
K895525 MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER Matrix Medica, Inc. DRL Class II 1990-01-26
K894922 WR3500 AND WR3600 SERIES RECORDERS Western Graphtec DSF Class I 1990-01-26
K896528 SFA MODULE Life Sciences Manufacturing, Inc. DXG Class II 1990-01-26
K900169 MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE Laerdal Mfg. Corp. LDD Class II 1990-01-26
K896809 MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR Medtronic Vascular DXY Class III 1990-01-26
K895732 JOBST ATHROMBIC PUMP(R) SYSTEM 2000 Jobst Institute, Inc. JOW Class II 1990-01-26
K894899 EXPANSION OF THE CORDIS PTA DILATATION CATHETER Cordis Corp. LIT Class II 1990-01-26
K895266 AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED Biosensor Corp. DSI Class II 1990-01-26
K896064 AMBULATORY CARDIAC MONITOR Monitech, Inc. DPS Class II 1990-01-26
K896690 MODIFIED ANGIOGRAPHIC CATHETER Novoste Corp. DQO Class II 1990-01-24
K896352 MODEL EC4542G MINIATURE Pace Medical DTE Class II 1990-01-24
K896264 MILLAR MIKRO-TIP DOPPLER CATHETER Millar Instruments, Inc. JOP Class II 1990-01-24
K895318 B-D ANGIOGRAPHIC CONTROL SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic DXT Class II 1990-01-19
K896819 VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION Baxter Healthcare Corp KRA Class II 1990-01-19
K896153 MODIFIED DR-2C/PMC 100 General Devices DSH Class II 1990-01-19
K896002 CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER Instromedix, Inc. DXH Class II 1990-01-19
K894944 BALLOON DILATATION CATHETER Peripheral Systems Group LIT Class II 1990-01-19
K896788 DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF Advanced Medical Instruments, Inc. DXQ Class II 1990-01-19
K895427 MEDISEAL SUCTION CANISTER Deroyal Industries, Inc. DWD Class II 1990-01-19
K896307 INSULATION PAD Bio-Vascular, Inc. DWS Class I 1990-01-19
K896415 USCI PRESTO DISPOSABLE INFLATION DEVICE C.R. Bard, Inc. DXT Class II 1990-01-19
K895146 GUIDING CATHETER Peripheral Systems Group DQO Class II 1990-01-19
K894631 NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW. Nihon Kohden America, Inc. DPW Class II 1990-01-19
K896034 PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM D. E. Hokanson, Inc. DSB Class II 1990-01-18
K895662 DEFIB K-PADS Katecho, Inc. LDD Class II 1990-01-18
K896102 MICRO FD 7000 AMBULATORY BLOOD PRESSURE MONITOR Advanced Medical Products, Inc. DXN Class II 1990-01-18
K893940 POLYSTAN HEATER-COOLER UNIT Polystan C/O Vitalcor, Inc. DWC Class II 1990-01-18
K896396 MIDA SYSTEM, MODELS 1000/1100 Medical Graphics Corp. DYC Class II 1990-01-18
K896535 MEDILOG OPTIMA Oxford Medilog, Inc. DSK Class II 1990-01-18
K896184 KALOS 05 PULSE GENERATOR Biotronik Cardiac Pacemakers DXY Class III 1990-01-18
K894856 CARDIOPHONE Euro-American Marketing Group, Inc. DXH Class II 1990-01-18
K896103 MICRO FL 7400 AMBULATORY HOLTER/BP MONITOR Advanced Medical Products, Inc. DSI Class II 1990-01-18
K896569 ELECTROTRACE DISPOSABLE AG/AGCL EKG MONITOR ELEC. Jason Marketing Co. DRX Class II 1990-01-18
K894295 ASTRO-MED ASC-951 PRESSURE PROCESSOR Astro-Med, Inc. DRQ Class II 1990-01-18
K892528 FIVE-YEAR STERILE PACKAGING SHELF LIFE Daig Corp. DTB Class III 1990-01-18
K896108 THE PILOT SCIMED TORQUE DEVICE Scimed Life Systems, Inc. LOX Class II 1990-01-09
K894628 MODEL DS-3300 DYNASCOPE PATIENT MONITOR Fukuda Denshi USA, Inc. DSI Class II 1990-01-08
K895903 IVT 0.014 GUIDE WIRE Intensive Technology, Inc. DQX Class II 1990-01-04
K895961 MODEL MC6500 ELECTROCARDIOGRAPH Cambridge Medical Instruments, Inc. DSH Class II 1990-01-04
K895932 PSG(TM) EDM(TM) INFUSION CATHETER Peripheral Systems Group DQY Class II 1990-01-04
K895878 OLYMPUS VALVULOTOME W/DETACHABLE TIP Olympus Corp. DWX Class II 1990-01-02
K885221 MULTILUMEN CENTRAL VENOUS CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic DQO Class II 1989-12-28
K885161 VOSS VEIN CLAMP Voss Medical Products DXC Class II 1989-12-22
K893705 SAFE-1 VENOUS RESERVOIR Polystan C/O Vitalcor, Inc. DTN Class II 1989-12-22
K893704 SAFE-1 Polystan C/O Vitalcor, Inc. DTZ Class II 1989-12-22
K893877 BIOCHEM 3100 OXIMETER Biochem International, Inc. DQO Class II 1989-12-20
K894492 NKA MODEL SEC-3102 CARDIAC STIMULATOR Nihon Kohden America, Inc. DRO Class II 1989-12-20
K895447 ENDOCARDIAL SCREW-IN LEAD MODEL 1020T Pacesetter Systems DTB Class III 1989-12-20
K896443 MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS Possis Medical, Inc. DTB Class III 1989-12-20
K895836 INFLATION PRO II Baxter Healthcare Corp MAV Class II 1989-12-20
K896632 MEDTRONIC MODEL 5401B TEST CABLE Medtronic Vascular DTC Class II 1989-12-13
K895009 GEL-TAC(R) Padeco, Inc. LDD Class II 1989-12-13
K894356 DISP. POLYMER (HYDROGEL) EXTERNAL PACING & DEFIB. Phycon LDD Class II 1989-12-13
K894736 MT96000 PAPER CHART RECORDER Astro-Med, Inc. DSF Class I 1989-12-13
K895916 PE INTERCARDIAC MAPPING SYSTEM (ICMS) Prucka Engineering, Inc. DRF Class II 1989-12-13
K896155 RED DOT CARDIAC SENSOR SYSTEM 3M Company DRX Class II 1989-12-13
K895691 VASCULAR CLAMP Applied Vascular Devices, Inc. DXC Class II 1989-12-13
K896386 MINIMON 7133B PATIENT MONITOR Kontron Instruments, Inc. DPS Class II 1989-12-13
K895651 MARQUETTE 1200 DEFIBRILLATION PADS Marquette Electronics, Inc. LDD Class II 1989-12-12
K893207 CLOSED CHEST SUPPORT CIRCUIT Medtronic Blood Systems, Inc. DTZ Class II 1989-12-12
K895208 ZYMED MODEL 1610 Agilent Technologies DSI Class II 1989-12-12
K895632 SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380 3M Company DTZ Class II 1989-12-12
K896417 KONTRON KOLORMON 7250 PATIENT MONITOR Kontron Instruments, Inc. DPS Class II 1989-12-12
K894355 DISP. GEL EXTERNAL PACING & DEFIBRILLATION ELECT. Phycon LDD Class II 1989-12-12
K892368 RMI CARDIOPLEGIA DELIVERY SETS Research Medical, Inc. DTL Class II 1989-12-07
K892377 RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET Research Medical, Inc. DTL Class II 1989-12-07
K883852 CATHETER, CARDIOVASCULAR, BALLOON TYPE Wb Intl., Inc. DXE Class II 1989-12-07
K895789 UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490 Medtronic Vascular LDF Class II 1989-12-07
K895721 MILLAR MIKRO-TIP PULSE TRANSDUCER Millar Instruments, Inc. DXO Class II 1989-12-07
K891121 MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM Boston Scientific Corp DYB Class II 1989-12-05
K893660 ECG SIMULATOR MODEL ECGPLUS Bio-Tek Instruments, Inc. DPS Class II 1989-12-05
K895393 SARNS INGANT MEMBRANE OXYGENATOR 3M Company DTZ Class II 1989-12-04
K892890 STETH-SHIELD(TM) North East Technology DQD Class II 1989-12-01
K894446 ANGEION HEMOSTASIS VALVE INTRODUCER Angeion Corp. DYB Class II 1989-11-30
K895278 SCD KNEE IMMOBILIZER Kendall Healthcare Products Co. Div.Of Tyco Health JOW Class II 1989-11-30
K895352 KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN Kendall Healthcare Products Co. Div.Of Tyco Health DWF Class II 1989-11-29
K895440 QUINTON MAHURKAR CATHETERS W/VITACUFF Quinton, Inc. DQY Class II 1989-11-29
K895429 A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2650 A&D Engineering, Inc. DXN Class II 1989-11-28
K895428 A&D AUTOMATIC DIGITAL BLOOD PRESSURE METER 2510/20 A&D Engineering, Inc. DXN Class II 1989-11-28
K893678 DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H Medtronic Blood Systems, Inc. KRH Class II 1989-11-27
K894168 SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F Baxter Healthcare Corp DQO Class II 1989-11-27
K895545 V*S*R(TM) SCOPE Vsr Enterprises Corp. LDE Class I 1989-11-15
K895454 SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK) Advance Medical Designs, Inc. DRC Class II 1989-11-14
K895753 BREVET DISPOSABLE CONNECTORS Brevet, Inc. DQY Class II 1989-11-14
K895214 HEMOSTASIS VALVE Applied Vascular Devices, Inc. DYB Class II 1989-11-14
K895455 SELDINGER PERCUTANEOUS 2 PC NEEDLES Advance Medical Designs, Inc. DRC Class II 1989-11-14
K893041 NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI Telectronics Pacing Systems, Inc. DTB Class III 1989-11-14
K892856 NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS Acacia Laboratories, Inc. KRI Class I 1989-11-08
K892941 CCO SYSTEM MODEL SP1467,SP5567,SP6267 Spectramed, Inc. KRB Class II 1989-11-06
K895268 ARROW HANDS-OFF THERMO-PACE Arrow Intl., Inc. DQO Class II 1989-11-06
K895834 BABY MAC ELECTROCARDIOGRAPH ELECTRODE Marquette Electronics, Inc. DRX Class II 1989-11-03
K895076 CMS VRB-1200 Cobe Laboratories, Inc. DTN Class II 1989-11-03
K894980 BIO-CAL 370 HEATER/COOLER Bio Medicus, Inc. DWJ Class II 1989-11-02

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