meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
47
Latest Decision
1999-11-19

Clearances · page 105 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K992832 SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS Sulzermedica DSY Class II 1999-11-19
K992964 IBC VENT VALVE, MODEL 1400 International Biophysics Corp. MNJ Class II 1999-11-19
K993555 MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES Masimo Corp. DQA Class II 1999-11-19
K991786 MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION General Electric Medical Systems Information Techn DPS Class II 1999-11-18
K992776 UNI-GRAFT K DV PATCH Atrium Medical Corp. DXZ Class II 1999-11-16
K991059 SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 Spectranetics Corp. DQY Class II 1999-11-16
K993620 IMPRESARIO Del Mar Medical Systems, LLC DQK Class II 1999-11-12
K992777 CONSTELLATION CATHETERS, MODEL 8039 Boston Scientific Corp MTD Class II 1999-11-12
K992863 LEAD STYLET,MODELS 6505,6506,6507,6508 Guidant Corp. DRB Class II 1999-11-12
K993434 PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A Biotronik, Inc. DXY Class III 1999-11-10
K992833 VACUUM ASSIST STABILIZER Cardio Thoracic Systems MWS Class I 1999-11-10
K992906 COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT Olson Medical Sales, Inc. DTL Class II 1999-11-10
K992857 LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 Rocky Mountain Research, Inc. DTW Class II 1999-11-10
K992674 HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A Hewlett-Packard GmbH MHX Class II 1999-11-08
K993516 HP M2600A VIRIDIA TELEMETRY SYSTEM Hewlett-Packard Co. DSI Class II 1999-11-08
K990103 MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE Sorin Biomedical, Inc. DTZ Class II 1999-11-05
K992373 ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE C.R. Bard, Inc. DRF Class II 1999-11-05
K991486 ULTRA-CBX Medcanica, Inc. DWZ Class II 1999-11-05
K992637 MUSE CARDIOVASCULAR INFORMATION SYSTEM General Electric Medical Systems Information Techn DSI Class II 1999-11-03
K993000 BARD HYDROPHILIC COATED GUIDE WIRES C.R. Bard, Inc. DQX Class II 1999-11-02
K992599 DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR Dideco S.P.A. DTN Class II 1999-11-01
K992323 DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES Datex-Ohmeda, Inc. MLD Class II 1999-11-01
K993245 CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM Alba Critical Care, Ltd. DYG Class II 1999-10-28
K991601 DUAL LUMEN CATHETER, MODEL DL-35-90 Endologix, Inc. DQY Class II 1999-10-28
K992169 ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE Advanced Cardiovascular Systems, Inc. DQX Class II 1999-10-28
K993266 PROWLER PLUS INFUSION CATHETER Cordis Neurovascular, Inc. KRA Class II 1999-10-28
K982521 SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES Leonhard Lang Co. DRX Class II 1999-10-26
K993341 INTELLISYSTEM II COLOR MONITOR Merit Medical Systems, Inc. MAV Class II 1999-10-25
K990713 SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER Spectranetics Corp. DRB Class II 1999-10-22
K991556 ZOLL M SERIES 12SL ANALYSIS OPTION Zoll Medical Corp MKJ Class III 1999-10-21
K993171 HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A Hewlett-Packard Co. DSI Class II 1999-10-21
K993257 .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI Micro Therapeutics, Inc. DQX Class II 1999-10-21
K992425 TES-20 Tes Electrical Electronic Corp. MWJ Class II 1999-10-19
K992478 PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A Hewlett-Packard, Healthcare Solutions Group DXN Class II 1999-10-15
K983616 DAIWA MODEL 180 Daiwa Products, Inc. DXN Class II 1999-10-15
K991025 LUMA-CATH FIXED CURVE EP CATHETERS Irvine Biomedical, Inc. DRF Class II 1999-10-15
K992056 ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 Sulzer Carbomedics, Inc. KRH Class II 1999-10-12
K992673 VISTA BRITE TIP CATHETERS Cordis Corp. DQY Class II 1999-10-12
K992238 MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12) Masimo Corp. DQA Class II 1999-10-08
K992340 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE Masimo Corp. DQA Class II 1999-10-08
K992347 CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS Cordis Corp. DQO Class II 1999-10-08
K991452 COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR Cobe Cardiovascular, Inc. DTZ Class II 1999-10-07
K992309 INTRODUCER SHEATH, VESSEL DILATOR Boston Scientific Corp DYB Class II 1999-10-07
K990638 ANEROID SPHYGMOMANOMETER Genmed, Inc. DXN Class II 1999-10-07
K992696 ECG MINIMONITOR, MODEL CG-5000 Card Guard Scientific Survival , Ltd. DXH Class II 1999-10-07
K993057 MBA Merit Medical Systems, Inc. DTL Class II 1999-10-05
K991531 CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 Cordis Webster, Inc. DRF Class II 1999-10-04
K990276 POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER Porous Media Corp. KRJ Class II 1999-10-01
K992960 ADVANTA GRAFT (>6MM) Atrium Medical Corp. DSY Class II 1999-10-01
K990396 T-ANASTAFLO Edwards Lifesciences Research Medical DWF Class II 1999-10-01
K992958 ADVANTA GRAFT (<6MM) Atrium Medical Corp. DYF Class II 1999-10-01
K992079 KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 The Kendall Company, L.P. JOW Class II 1999-09-29
K991540 WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER AngioDynamics, Inc. LIT Class II 1999-09-29
K992622 INTRAMAX ITI GUIDE CATHETER Intratherapeutics, Inc. DQY Class II 1999-09-29
K992968 CARTO EP NAVIGATION SYSTEM Biosense Webster, Inc. DQK Class II 1999-09-29
K991646 AGILITY STEERABLE GUIDEWIRE Cordis Neurovascular, Inc. DQX Class II 1999-09-23
K992559 HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010 Jostra Bentley DTZ Class II 1999-09-20
K990378 STATVIEW SYSTEM Data Critical Corp. MSX Class II 1999-09-20
K992772 CARDIOPHONICS 1000 MEMORY MONITOR Rlt Medical Assoc., Inc. DXH Class II 1999-09-17
K983717 BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM Aerotel Medical Systems (1998) , Ltd. DXN Class II 1999-09-16
K990642 ECHOFLOW DOPPLER BLOOD VELOCITY METER Echocath, Inc. JOP Class II 1999-09-16
K992910 AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) Medtronic Vascular DTZ Class II 1999-09-15
K983232 PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT Tz Medical, Inc. DRO Class II 1999-09-15
K983196 PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) Tz Medical, Inc. DRO Class II 1999-09-15
K992825 CORDIS EXTREME PTA BALLOON CATHETER Cordis Corp. LIT Class II 1999-09-15
K991066 MADTRONIC DLP ARTERIAL CANNULAE Medtronic Vascular DWF Class II 1999-09-14
K992237 MEDTRONIC GT2 FUSION GUIDE WIRES Medtronic Vascular DQX Class II 1999-09-09
K991683 PTFE RINGED GORE-TEX VASCULAR GRAFT W. L. Gore & Associates, Inc. DYF Class II 1999-09-08
K992640 SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS Minumys Surgical, Inc. DXC Class II 1999-09-08
K991973 CAPIOX SX10 HARDSHELL RESEVOIR Terumo Medical Corp. DTN Class II 1999-09-03
K990762 ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) Zoll Medical Corp MKJ Class III 1999-09-03
K991910 LIFEPAK 12 BIPHASIC Physio-Control Corp. MKJ Class III 1999-09-03
K990494 MODIFICATION OF NOGA Biosense, Inc. DQK Class II 1999-09-03
K992808 A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE A&D Medical Div. DXN Class II 1999-09-01
K990412 CUFF-ABLE PLUS Vital Signs, Inc. DXQ Class II 1999-09-01
K990338 NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM Physio-Control Corp. DXN Class II 1999-09-01
K990487 EQUINOX OCCLUSION BALLOON SYSTEM Micro Therapeutics, Inc. MJN Class II 1999-08-31
K990478 CARD GUARD, MODEL CG-6550 Card Guard Scientific Survival , Ltd. DXH Class II 1999-08-31
K992636 HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A Hewlett-Packard Co. DXJ Class II 1999-08-31
K990271 ENDOSONICS TRAK BACK DEVICE Endosonics Corp. DQX Class II 1999-08-30
K992164 TELEMEDICINE 2000 Card Guard Scientific Survival , Ltd. DXH Class II 1999-08-30
K991823 N-395 PULSE OXIMETER, MODEL N-395 Nellcor Puritan Bennett, Inc. DQA Class II 1999-08-25
K991007 K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 Katecho, Inc. MKJ Class III 1999-08-23
K992123 SCIMED IMPULSE ANGIOGRAPHIC CATHETERS Boston Scientific Scimed, Inc. DQO Class II 1999-08-23
K992441 ADVANTA GRAFT Atrium Medical Corp. DYF Class II 1999-08-20
K992443 ADVANTA GRAFT Atrium Medical Corp. DSY Class II 1999-08-20
K991819 MAGNATEK 30 Magna Advanced Technologies, Inc. DQA Class II 1999-08-19
K992413 ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR Medical Data Electronics DRT Class II 1999-08-19
K984338 JOSTRA HL-20 TWIN PUMP Jostra Bentley DPW Class II 1999-08-19
K992411 ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR Medical Data Electronics DRT Class II 1999-08-18
K984214 CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER Cordis Neurovascular, Inc. DXC Class II 1999-08-10
K990648 KELLER VITAL SIGNS MONITOR, KMS 890+ Keller Medical Specialties Products, Inc. DXN Class II 1999-08-10
K992051 RADIFOCUS OPTITORQUE Terumo Medical Corp. DQO Class II 1999-08-10
K991871 HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A Hewlett-Packard Co. MKJ Class III 1999-08-05
K992387 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100 Rossmax International , Ltd. DPW Class II 1999-08-03
K992388 ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200 Rossmax International , Ltd. DPW Class II 1999-08-03
K990142 HT, MODEL HT PB Sulzer Oscor, Inc. DTB Class III 1999-07-30
K983802 LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB Lucas Medical, Inc. MJN Class II 1999-07-30
K984482 AVE GL-1 GUIDING CATHETER Arterial Vascular Engineering Massachusetts, Inc. DQY Class II 1999-07-30
K983270 VOYAGER QUAD CANNULA Cardiothoracic Systems, Inc. DWF Class II 1999-07-28

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