Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)2Cleared 510(K)
- K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)2Cleared 510(K)
- K233824Swan-Ganz catheter2Cleared 510(K)
- K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform2Cleared 510(K)
- K222117Swang-Ganz IQ pulmonary artery catheter2Cleared 510(K)
- K193466Swan-Ganz Catheters2Cleared 510(K)
- K160084Swan Ganz Catheters2Cleared 510(K)
- K094048PERCUPRO MESSENGER BALLOON CATHETER2Cleared 510(K)
- K081052OCCLUSION BALLOON CATHETER, MODEL VENOS2Cleared 510(K)
- K010253ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ1012Cleared 510(K)
- P810046RX CHASSIS 3 CORONARY DILATATION CATHETER2PMA Approval
- P810046VOYAGER OTW CORONARY DILATION CATHETER2PMA Approval
- P810046ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS2PMA Approval
- P810046HIGHSAIL CORONARY DILATATION CATHETERS2PMA Approval
- K012225ATTAIN 6215 VENOGRAM BALLOON CATHETER2Cleared 510(K)
- K003118Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-02Cleared 510(K)
- K001063SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF72Cleared 510(K)
- K993245CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM2Cleared 510(K)
- K963336HARMAC THERMODILUTION CATHETER2Cleared 510(K)
- K955816VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR2Cleared 510(K)
- K963248FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)2Cleared 510(K)
- K961999SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS2Cleared 510(K)
- K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]2Cleared 510(K)
- K940547FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED2Cleared 510(K)
- K940795SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER2Cleared 510(K)
- K935404FLOW DIRECTED THERMODILUTION BALLOON CATHETER2Cleared 510(K)
- K934742SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT2Cleared 510(K)
- K924452SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER2Cleared 510(K)
- K925444CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR2Cleared 510(K)
- K920869FLOW DIRECTED THERMODILUTION BALLOON CATHETER2Cleared 510(K)
- K911840INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER2Cleared 510(K)
- K901287INTHERM TEMPORARY OCCLUSION CATHETER2Cleared 510(K)
- K904287STEALTH DILATION CATHETER SYSTEM/MODIFICATION2Cleared 510(K)
- K901247TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES2Cleared 510(K)
- K900879SOFT-WEDGE(TM) SYRINGE2Cleared 510(K)
- K896466SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME2Cleared 510(K)
- K893435SILICONE FLOW-DIRECTED THERMODILUTION CATHETER2Cleared 510(K)
- K892530CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH2Cleared 510(K)
- K893474BARD CATH LAB THERMODILUTION CATHETER2Cleared 510(K)
- K883948MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER2Cleared 510(K)
- K874465SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD2Cleared 510(K)
- K874117MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE2Cleared 510(K)
- K872770DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.2Cleared 510(K)
- K862119DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR2Cleared 510(K)
- K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN2Cleared 510(K)
- K852294BARD-PARKER OCCLUSION BALLOON CATHETER2Cleared 510(K)
- K850952BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI2Cleared 510(K)
- K851948MEDTRONIC MODEL 64042Cleared 510(K)
- K843411THERMAL DILUTION CATHETER2Cleared 510(K)
- K843409FLOW-DIRECTED THERMODILUTION CATH2Cleared 510(K)
- K841639NOVA BALLOON THERMODILUTION CATH.2Cleared 510(K)
- K841640NOVA BALLOON THERMODILUTION INFUSION2Cleared 510(K)
- K841876POLYURETHANE THERMAL DILUTION CATHET2Cleared 510(K)
- K841705WEDGE PRESSURE CATHETER FLOW DIRECTED2Cleared 510(K)
- K841317DESERET HEPARIN COATED FLOW DIRECTED2Cleared 510(K)
- K841251DESERET HEPARIN COATED FLOW CATH2Cleared 510(K)
- K833836IL HEPARINIZED FLOW DIRECTED THERMAL2Cleared 510(K)
- K833918INFUSION PORT BALLOON THERMODILUTION2Cleared 510(K)
- K833572HEPARIN-COATED BALLOON THERMODILUT2Cleared 510(K)
- K834037HEPARIN COATED BALLOON THERMODILU2Cleared 510(K)
- K834036HEPARIN COATED BALLOON THERMODILU2Cleared 510(K)
- K832380PROTECTIVE SLEEVE2Cleared 510(K)
- K832324THERMAL DILUTION CATHETER2Cleared 510(K)
- K831854USCI ANGIOGRAPHIC BALLOON CATHETER2Cleared 510(K)
- K832287NOVA BALLOON THERMODILUTION INFUSION2Cleared 510(K)
- K832957FLOW-DIRECTED HEPARIN COATED THERMODIL2Cleared 510(K)
- K831945ELECATH BALTHERM TLC THERMAL DILUTION2Cleared 510(K)
- K830604WEDGE PRESSURE CATHETER2Cleared 510(K)
- K831185CARDIAC OUTPUT MEASURE SYSTEM2Cleared 510(K)
- K823484THERMAL DILUTION CATHETER2Cleared 510(K)
- K823433BALLOON THERMODILUTION CATHETER #7164&2Cleared 510(K)
- K823007OPTICATH HEPARIN COATED, FLOW-DIRECT2Cleared 510(K)
- K822806BALLOON WEDGE PRESSURE, ANGIOGRAPHIC2Cleared 510(K)
- K822723SWAN-GANZ BIPOLAR PACING CATHETER2Cleared 510(K)
- K822350SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH2Cleared 510(K)
- K822034BALLOON WEDGE PRESSURE CATHETER2Cleared 510(K)
- K821996LEONARD PERIPHERAL VENOUS PRESSURE CATH2Cleared 510(K)
- K821004MEDTRONIC S3 TM SYSTEM2Cleared 510(K)
- K821235HEPARIN COATED THERMODILUTION CATHETER2Cleared 510(K)
- K821099HEPARIN COATED THERMODILUTION CATHETER2Cleared 510(K)
- K821057FLOW DIRECTED THERMAL-DILUTION INFUSION2Cleared 510(K)
- K820883SEPTISLEEVE2Cleared 510(K)
- K820702IL 7F FLOW DIRECTOR THERMAL DILU. CATH2Cleared 510(K)
- K820229NORTON FLOW DIRECTED THERMODILUTION CATH2Cleared 510(K)
- K820222SWAN-GANZ VIP-CATHETER2Cleared 510(K)
- K813578HEMOSTATIC SIDE-ARM ADAPTER2Cleared 510(K)
- K812111PRUITT ARTERIAL OCCLUSION CHOLANG. CATH2Cleared 510(K)
- K812563SWAN-GANZ & EDSLAB HEPARIN COATED CATH.2Cleared 510(K)
- K812324FLOW-DIRECTED THERMODILUTION CATHETER2Cleared 510(K)
- K811276OCCLUSION CATHETER2Cleared 510(K)
- K810352SWAN-GANZ FLOW-DIRECTED THERMODILUTION2Cleared 510(K)
- K810124SWAN-GANZ VIP THERMODILUTION CATHETER2Cleared 510(K)
- K802288SWAN GANZ CATHETER PLACEMENT KIT2Cleared 510(K)
- K8024817FRENCH FLOW DIRECTED TRIPLE LUMEN CATH2Cleared 510(K)
- K802338TORQUE CONTROL BALLOON CATHETER2Cleared 510(K)
- K801865CORDIS FLOW DIRECTED BALLOON CATHETER2Cleared 510(K)
- K782071CATHETER, USCI GRUNTZIG/BALLOON2Cleared 510(K)
- K771823CATHETER, CARDIOVASCULAR2Cleared 510(K)
- K771043SWAN GANZ2Cleared 510(K)
- K772059CATHETER, PACING/MONITORING2Cleared 510(K)
- K771306THERMOCATH2Cleared 510(K)
- K770522CATHETER, GRUNTZIG, BALLON2Cleared 510(K)
- K760533CATHETER, FLOW DIRECTED THERMAL DILUTION2Cleared 510(K)
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- NPGCatheter, Infusion, Syringe2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
- Page Type
- Cleared 510(K)
- 510(k) Number
- K853383
- 510(k) Type
- Traditional
- Applicant
- WEBSTER LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/3/1985
- Days to Decision
- 113 days