meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
1997-02-26

Clearances · page 114 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K964112 BERENSTEIN COIL Target Therapeutics KRD Class II 1997-02-26
K962981 CAPIOX SP PUMP HEAD Terumo Medical Corp. KFM Class II 1997-02-25
K963678 CARETONE II American Telecare, Inc. DQD Class II 1997-02-24
K962827 ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) Marquette Electronics, Inc. DSI Class II 1997-02-24
K964055 FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) Epic Medical Equipment Services, Inc. DQA Class II 1997-02-21
K965249 SPYGLASS ANGIOGRAPHIC CATHETER Daig Corp. DQO Class II 1997-02-21
K962765 CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS) Cordis Corp. DQX Class II 1997-02-21
K963000 MAXI LD PTA BALLOON CATHETER Cordis Corp. LIT Class II 1997-02-20
K964665 VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) Carbomedics, Inc. DSY Class II 1997-02-19
K964648 PROTECT ALL BLOOD PRESSURE CUFF COVER Protect All, Inc. DXQ Class II 1997-02-18
K961246 SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M St. Jude Medical, Inc. KRH Class II 1997-02-14
K962717 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING Biocompatibles Cardiovascular, Inc. DQY Class II 1997-02-12
K964697 AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION Advance Medical Device, Inc. DXN Class II 1997-02-11
K945290 8500A PULSE OXIMETER Nonin Medical, Inc. DQA Class II 1997-02-11
K962835 HEARTPORT ENDOVENOUS DRAINAGE CANNULA Heartport, Inc. DWF Class II 1997-02-10
K964859 SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS Scimed Life Systems, Inc. DQO Class II 1997-02-10
K953175 AS/3 ESTPR MODULE Datex Division Instrumentarium Corp. MLD Class II 1997-02-06
K962603 MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES Masimo Corp. DQA Class II 1997-02-06
K953976 SAFE MICRO Polystan A/S DTZ Class II 1997-02-04
K963104 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM Arrow Intl., Inc. DSP Class II 1997-02-04
K963248 FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) J-Lloyd Medical, Inc. DYG Class II 1997-02-03
K964662 FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15 Rmds, Inc. DXC Class II 1997-02-03
K964390 CHASE VESSEL OCCLUDER Chase Medical, Inc. MJN Class II 1997-01-31
K964445 OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) Dlp, Inc. DWS Class I 1997-01-30
K962291 SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM Siemens Medical Solutions USA, Inc. DSI Class II 1997-01-29
K922668 PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM Colin Medical Instruments Corp. MHX Class II 1997-01-29
K955802 PATHFINDER Cardima, Inc. DRF Class II 1997-01-29
K955847 GYRO TIP EP CATHETER Cardiac Assist Devices, Inc. DRF Class II 1997-01-29
K964352 TORQUE DEVICE B.Braun Medical, Inc. DQX Class II 1997-01-28
K964611 TRANSEND GUIDEWIRE Boston Scientific Corp DQX Class II 1997-01-28
K963067 SOF. PRESS EPC 51 SYSTEM Gaymar Industries, Inc. JOW Class II 1997-01-28
K962655 ANEROID AND MERCURIAL SPHYGMOMANOMETERS American Diagnostic Corp. DXQ Class II 1997-01-27
K963929 JOBST ATHROMBIC PUMP SYSTEM 2100 Jobst A Beiersdorf Co. JOW Class II 1997-01-27
K961845 PERCUPUMP II WITH EDA E-Z-Em, Inc. DSB Class II 1997-01-23
K964272 PERFORMR SERIES EP DIAGNOSTIC CATHETERS Medtronic Cardiorhythm DRF Class II 1997-01-23
K961847 HEMASHIELD VANTAGE (VASCULAR GRAFT Meadox Medicals, Div. Boston Scientific Corp. DSY Class II 1997-01-22
K963702 ACS HI-TORQUE IRON MAN GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1997-01-22
K964248 HEARTPORT ENDOCORONARY SINUS CATHETR Heartport, Inc. DWF Class II 1997-01-22
K955023 BRENTWOOD PC-ECG Brentwood Medical Products, Inc. DSI Class II 1997-01-22
K962404 SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM Siemens Medical Solutions USA, Inc. DSI Class II 1997-01-17
K964991 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES Cardiotronics Systems, Inc. MKJ Class III 1997-01-15
K964154 SEGUE INFUSION CATHETER Interventional Innovations Corp. KRA Class II 1997-01-14
K961883 VERSA-CATH ARTERIAL CATHETER Ideas For Medicine, Inc. DXE Class II 1997-01-13
K963092 MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER Adam Spencer Corp. DQO Class II 1997-01-13
K963663 11F GUIDING CATHETER Boston Scientific /International Technologies DQY Class II 1997-01-13
K960511 GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET Gibeck, Inc. DWJ Class II 1997-01-13
K964331 ASC HIGH PRESSURE BRAIDED TUBES Adam Spencer Corp. DQO Class II 1997-01-13
K962320 S3 CARDIOPLEGIA CONTROL Stoeckert Instrumente DTR Class II 1997-01-10
K964547 DEGANIA SILICONE INDENTI LOOPS Degania Silicone , Ltd. DXC Class II 1997-01-08
K964122 HP STAR ST AND ARRHHYTHMIA SOFTWARE Hewlett-Packard Co. DSI Class II 1997-01-08
K962978 CCENTERMARK CATHETER INTRODUCER SHEALTH WITH PROTECTIV 2000 NEEDLE SAFETY SYSTEM Johnson & Johnson Medical, Inc. DYB Class II 1997-01-07
K963975 VERSATEC 310 ELECTRODE Versatec, Inc. DRX Class II 1997-01-07
K964284 STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM Boston Scientific Corp DTK Class II 1997-01-06
K963672 MODEL 90022 ROLLING STAND Augustine Medical, Inc. JOW Class II 1997-01-06
K964197 IMPRA CARBOFLO EPTFE VASCULAR GRAFT Impra, Inc. DSY Class II 1997-01-02
K961992 NEEDLE'S EYE SNARE Cook Pacemaker Corp. DXE Class II 1996-12-27
K961405 ALBA HEALTH PAS WRAP SYSTEM Alba-Waldensian, Inc. JOW Class II 1996-12-26
K961780 HEMODIALYSIS INTRODUCER SET Thomas Medical Products, Inc. DYB Class II 1996-12-24
K962424 NPB-4000 Analogic Corp. MHX Class II 1996-12-20
K964554 PERSONAL TELEMEDICINE MODULE American Telecare, Inc. DRG Class II 1996-12-17
K962572 SCIMED CHOICE PT VISION PTCA GUIDE WIRE Scimed Life Systems, Inc. DQX Class II 1996-12-17
K963749 HIGH PRESSURE INJECTION LINES Maxxim Medical DTL Class II 1996-12-17
K954642 HYDRO-SELECT GUIDEWIRE Microvena Corp. DQX Class II 1996-12-17
K954610 MODEL 430-07 ENDOCARDIAL PACING LEAD Intermedics, Inc. DTB Class III 1996-12-16
K962641 MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER Medtronic Vascular DTZ Class II 1996-12-16
K963707 NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) Nellcor Puritan Bennett, Inc. DQA Class II 1996-12-13
K963988 INTRAVASCULAR INFUSION DEVICE Boston Scientific Corp KRA Class II 1996-12-12
K963159 CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES Cmc Sense-It, Inc. DRX Class II 1996-12-11
K964469 700-F SERIES STIMULATION ELECTRODES Cardiotronics Systems, Inc. LDD Class II 1996-12-11
K961138 ESORT II + 400 SERIES MONITOR Medical Data Electronics DRO Class II 1996-12-10
K961937 SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM Delphi Consulting Group DQD Class II 1996-12-09
K961643 MEDICOTEST ECG ELECTRODES Medicotest, Inc. DRX Class II 1996-12-09
K961530 GISH RELIANCE OXYGENATOR (MODEL HFO) Gish Biomedical, Inc. DTZ Class II 1996-12-05
K963811 CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE Card Guard Scientific Survival , Ltd. DXH Class II 1996-12-04
K952315 SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE Emg Scientific DQA Class II 1996-12-04
K963621 STETHOS Theratechnologies, Inc. DQD Class II 1996-12-04
K960970 POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P Possis Medical, Inc. MCW Class II 1996-12-03
K963320 TFX MEDICAL GUIDEWIRE Tfx Medical Group DQX Class II 1996-12-03
K963496 OXI TEMP Bci Intl., Inc. DQA Class II 1996-11-26
K963400 NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER Nellcor Puritan Bennett, Inc. DPS Class II 1996-11-26
K963183 BIOZ SYSTEM Cardiodynamics International Corp. DSB Class II 1996-11-26
K964213 TRACE RITE SOLID GEL ECG ELECTRODES Bio-Detek, Inc. DRX Class II 1996-11-25
K962128 TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT) Hemo Sapiens, Inc. DXG Class II 1996-11-21
K963611 VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH Vascutek, Ltd. DXZ Class II 1996-11-21
K951226 VITALMAX 4000/MINIPACK 3100/3000 Pace Tech, Inc. DSK Class II 1996-11-21
K961917 MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) Medtronics Interventional Vascular DQX Class II 1996-11-20
K962771 BURKE CONGENITAL THORACOSCOPY INSTRUMENTS Pilling Weck, Inc. DWS Class I 1996-11-19
K962551 CARDIOSERV S Marquette Electronics, Inc. LDD Class II 1996-11-19
K961999 SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc. DYG Class II 1996-11-19
K963151 MEDI-TRACE 5700 RESTING ECG ELECTRODE Graphic Controls Corp. DRX Class II 1996-11-19
K963016 SIMON NITINOL FILTER SYSTEM Nitinol Medical Technologies, Inc. DTK Class II 1996-11-18
K963014 SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM Nitinol Medical Technologies, Inc. DTK Class II 1996-11-18
K963038 MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE Graphic Controls Corp. DRX Class II 1996-11-15
K961333 HEARTPORT MULTIFIRE CLIP APPLIER Heartport, Inc. DSS Class II 1996-11-15
K961509 INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED Datascope Corp. DSP Class II 1996-11-15
K952827 FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 Sein Electronics Co., Ltd. DXN Class II 1996-11-14
K952826 FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000 Sein Electronics Co., Ltd. DXN Class II 1996-11-14
K961520 UNIPOLAR IPG GROUND CABLE, MODEL 5473 Medtronic Vascular LDF Class II 1996-11-13
K963214 CORDIS ST STEERABLE GUIDEWIRE Cordis Corp. DQX Class II 1996-11-13
K961582 EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100 North American Technical Services Corp. DTC Class II 1996-11-08

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