meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
42
Latest Decision
1989-02-10

Clearances · page 145 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K883977 SURGI-CUF STERILE/NON-STERILE DISPOSABLE Ethox Corp. DXQ Class II 1989-02-10
K884733 AFP MODEL 262T PULSE GENERATOR Pacesetter Systems DXY Class III 1989-02-10
K883412 THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) Promedica Products, Inc. DWF Class II 1989-02-08
K884895 ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1989-02-06
K884887 MODEL 499 SSR ANALYSIS SYSTEM Del Mar Avionics DSI Class II 1989-02-06
K884775 ARBO PINK H82P Arbo Medical, Inc. DRX Class II 1989-02-06
K890033 MODEL 8700 PULSE OXIMETER Nonin Medical, Inc. DQA Class II 1989-02-06
K884536 AL-800PA PULSE OXIMETER MODULE Nihon Kohden America, Inc. DQA Class II 1989-02-06
K890142 A10 ULTRASCOPE RECORDER Ems Medical, Inc. DSF Class I 1989-02-06
K884946 JEHLE CORONARY PERFUSION CATHETERS Pilling Co. KRA Class II 1989-02-06
K885188 MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY Quinton, Inc. DWF Class II 1989-02-06
K883845 RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER Phoenix Imaging DXK Class II 1989-02-03
K884619 PACH-PEN CALCULATOR Oculab, Inc. DXG Class II 1989-02-02
K890350 VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) Telectronics, Inc. DTB Class III 1989-02-02
K884645 PATIENT MONITOR RIGEL MODEL MULTICARE 429 Rigel Medical Electronics, Inc. DRT Class II 1989-02-02
K884742 ESCORT NON-INVASIVE BLOOD PRESSURE OPTION Medical Data Electronics DXN Class II 1989-02-02
K884662 PATIENT MONITOR MODEL 703 Ivy Biomedical Systems, Inc. DPS Class II 1989-02-02
K884624 MVL/MODULAB WITH PVR MODULE Life Sciences Manufacturing, Inc. JOM Class II 1989-02-01
K884614 EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS. Edentec Corp. DQA Class II 1989-02-01
K890045 MODEL 6208,6209,6210,6211,6212,6214 (PLI'S) Medtronic Vascular DTB Class III 1989-01-30
K884893 CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 American Omni Medical, Inc. KRI Class I 1989-01-30
K884872 DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR Shiley, Inc. DTN Class II 1989-01-30
K882658 ANGIOSCOPE FOR PULMONARY ARTERY USE Washington Regulatory Services DQO Class II 1989-01-26
K884411 OPTIMA MPT AND SPT PACEMAKERS Telectronics, Inc. DXY Class III 1989-01-26
K885235 SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. Spectramed, Inc. DSK Class II 1989-01-25
K885262 POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES Valleylab, Inc. DRX Class II 1989-01-25
K885296 MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F Baxter Healthcare Corp DRS Class II 1989-01-25
K883037 UNILITH 3 MODELS 7580/7583/7680/7683 Ela Medical, Inc. DXY Class III 1989-01-25
K883454 MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH Cambridge Medical Instruments, Inc. DPS Class II 1989-01-25
K884659 SARNS 9000 WITH CENTRIFUGAL PUMP OPTION 3M Health Care, Sarns KFM Class II 1989-01-24
K884640 CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 American Omni Medical, Inc. KRI Class I 1989-01-24
K890103 BARD TAB ECG MONITORING ELECTRODE C.R. Bard, Inc. DRX Class II 1989-01-24
K882826 SOFTRAC-PTA PERIPHERAL DILATATION CATHETER Schneider-Shilley (Usa) LIT Class II 1989-01-24
K882609 MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM Waltham Div. Hewlett Packard DRT Class II 1989-01-19
K884502 USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER C.R. Bard, Inc. DQO Class II 1989-01-18
K882825 TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN A&D Engineering, Inc. DXN Class II 1989-01-17
K883440 E550 ELECTROCARDIOGRAPH Burdick Corp. DSI Class II 1989-01-17
K883743 MEDTRONIC MODEL 4058 PACING LEAD Medtronic Vascular DTB Class III 1989-01-17
K883402 EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER) Quinton, Inc. DPS Class II 1989-01-17
K884490 INTRODUCER SAFETY SYRINGE Arrow Intl., Inc. DQX Class II 1989-01-17
K884539 HOLTER 24-HOUR ECG PLAYBACK, MODEL 150 Rmv Medical (Romavat, Inc.) DSI Class II 1989-01-17
K883109 MINIMON 7136B PATIENT MONITOR Kontron, Inc. DRT Class II 1989-01-17
K883069 MINIMON 7134B PATIENT MONITOR Kontron Instruments, Inc. DRT Class II 1989-01-17
K882824 TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR A&D Engineering, Inc. DXN Class II 1989-01-17
K885252 MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 Ep Technologies, Inc. DRQ Class II 1989-01-13
K884421 PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT Pymah Corp. DXQ Class II 1989-01-13
K884911 CORTRONIC SCR1000 Cortronic Corp. DSF Class I 1989-01-13
K883750 VENTRALITH I Bio Pace Technology, Inc. DXY Class III 1989-01-13
K884647 USCI ADJUSTABLE TIP GUIDE WIRE C.R. Bard, Inc. DQX Class II 1989-01-12
K884408 NAMIC DUAL BACKCHECK VALVE North American Instrument Corp. DTL Class II 1989-01-12
K884065 CATH LAB MONITORING CATHETER C.R. Bard, Inc. DQO Class II 1989-01-12
K884451 DOPCORD PPG Huntleigh Technology, Inc. JOM Class II 1989-01-12
K885171 MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE Andover Medical, Inc. DRO Class II 1989-01-12
K881771 SENSOCOR(TM) DIASYS Sensormedix, Inc. DXN Class II 1989-01-12
K884992 FUKUDA DENSHI MODEL FX-1201 Fukuda Denshi USA, Inc. DPS Class II 1989-01-12
K885101 MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR Medtronic Vascular DSA Class II 1989-01-12
K884083 TORAY VASCULAR PROSTHESIS Toray Industries (America), Inc. DSY Class II 1989-01-12
K884375 TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER Argon Medical Corp. DQR Class II 1989-01-11
K884310 ANGIOPUMP TUBING SET Olympus Corp. DWF Class II 1989-01-10
K884388 EDENTEC MODEL 4700 SCANNER Edentec Corp. DSF Class I 1989-01-10
K884481 CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE Mallinckroot, Inc. LIT Class II 1989-01-10
K884331 MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER Medtronic Vascular DTC Class II 1989-01-10
K882977 ASK-300 Medical Repackers Co. DQR Class II 1989-01-05
K884330 MODEL 463 ELECTROCARDIORECORDER RECORDER Del Mar Avionics DSH Class II 1989-01-05
K884337 MICRO-GUIDE SYSTEM Catheter Research C/O Burditt, Bowles & Radzius DRA Class II 1989-01-05
K884386 ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK Ethitek Pharmaceuticals Co. KRK Class II 1989-01-05
K884919 DISPOSABLE DOME STOCK #D-300 Advanced Medical, Inc. DRS Class II 1989-01-05
K883315 EDENTRACE MULTI-CHARTER MODEL 3700 Edentec Corp. DSF Class I 1988-12-28
K883617 LIFEPAK 50 MONITOR/DEFIBRILLATOR Physio-Control Corp. LDD Class II 1988-12-28
K884891 OC-100 OXIMETER INTERFACE CALIBRATOR Telediagnostic Systems, Inc. DQA Class II 1988-12-28
K884955 CARDIOCAP(TM) CM-104 MONITOR Datex Division Instrumentarium Corp. DXN Class II 1988-12-28
K882717 PROCEDURE PACKS CONTRAST MEDIA SETS Procedure Packs, Inc. DTL Class II 1988-12-28
K883909 SURGICAL SPRING CLIPS Applied Vascular Devices, Inc. DSS Class II 1988-12-27
K884274 BUCHBINDER MULTIFLEX GUIDEWIRE Medtronic Vascular DQX Class II 1988-12-27
K884956 CARDIOCAP(TM) CTO-104 MONITOR Datex Division Instrumentarium Corp. DPS Class II 1988-12-27
K883468 Q5000 ST/HR SLOPE MODIFICATION Quinton, Inc. DPS Class II 1988-12-27
K884393 MODIFIED SHILEY FEMORAL ARTERIAL CANNULA Shiley, Inc. DWF Class II 1988-12-27
K880505 ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301 Ppg Industries, Inc. DSI Class II 1988-12-27
K884320 PROPAQ 106(TM) Protocol Systems, Inc. DRT Class II 1988-12-27
K883790 SURGICAL CLAMP INSERTS Applied Vascular Devices, Inc. DXC Class II 1988-12-27
K884104 USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR C.R. Bard, Inc. DYB Class II 1988-12-21
K884262 ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1988-12-21
K884129 BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET Bio Medicus, Inc. DQY Class II 1988-12-21
K884390 INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER Medtronic Blood Systems, Inc. KRJ Class II 1988-12-21
K884209 USCI DORROS INFUSION/PROBING CATHETER Usci, Div. C.R. Bard, Inc. DQY Class II 1988-12-21
K884142 OXINET N-7500 PULSE OXIMETRY NETWORK Nellcor, Inc. DXH Class II 1988-12-16
K883919 NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER Naparima, Inc. DSB Class II 1988-12-16
K884329 SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER Baxter Healthcare Corp DQA Class II 1988-12-16
K880932 MRL PACETTE, 450SLL Medical Research Laboratories, Inc. DRO Class II 1988-12-16
K884278 IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 Telectronics, Inc. DTB Class III 1988-12-15
K884152 CENTURY COLOR TRACE Biomedical Systems, Inc. DSI Class II 1988-12-15
K881841 DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS Buckman Co., Inc. DSB Class II 1988-12-13
K882657 HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT Harbor Medical Devices, Inc. DYB Class II 1988-12-13
K884318 THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM Abbott Laboratories KRB Class II 1988-12-13
K884198 TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE Target Therapeutics DQX Class II 1988-12-13
K883888 CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. Advanced Biosearch Assn. DXK Class II 1988-12-12
K882289 ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. Aries Medical, Inc. DSY Class II 1988-12-12
K884394 PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F Ela Medical, Inc. DTB Class III 1988-12-08
K884244 INTERSEPT* PREBYPASS FILTER Medtronic Blood Systems, Inc. KRJ Class II 1988-12-05
K883070 ENCOR UNIPOLAR VS-1 LEADS Cordis Leads, Inc. DTB Class III 1988-12-05

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