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
- 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
- K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter2Cleared 510(K)
- K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter2Cleared 510(K)
- K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)2Cleared 510(K)
- K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter2Cleared 510(K)
- K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 4012Cleared 510(K)
- K240972Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)2Cleared 510(K)
- K233825Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter2Cleared 510(K)
- K221067Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter2Cleared 510(K)
- K221854Reprocesses Umbilical Cable2Cleared 510(K)
- K211276Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters2Cleared 510(K)
- K203655Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)2Cleared 510(K)
- K200205Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled2Cleared 510(K)
- K193263Reprocessed Achieve Catheter Connecting Cable2Cleared 510(K)
- K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter2Cleared 510(K)
- K190127Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter2Cleared 510(K)
- K182488Reprocessed Response Diagnostic Electrophysiology Catheter2Cleared 510(K)
- K181056Reprocessed CS Diagnostic Electrophysiology Catheter2Cleared 510(K)
- K181897Reprocessed Marinr Diagnostic EP Catheter2Cleared 510(K)
- K181458Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter2Cleared 510(K)
- K181618Reprocessed Torqr Diagnostic EP Catheter2Cleared 510(K)
- K180710Reprocessed DecaNav Diagnostic Electrophysiology Catheter2Cleared 510(K)
- K171788Reprocessed Halo XP Diagnostic Electrophysiology Catheter2Cleared 510(K)
- K171503Reprocessed CristaCath Diagnostic Electrophysiology Catheter2Cleared 510(K)
- K170922Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)2Cleared 510(K)
- K161272Supreme and Response Electrophysiology Catheters2Cleared 510(K)
- K162251Reprocessed Viking Diagnostic Electrophysiology Catheters2Cleared 510(K)
- K161827Reprocessed Response Diagnostic Electrophysiology Catheters2Cleared 510(K)
- K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter2Cleared 510(K)
- K161393Reprocessed Orbiter ST Steerable Diagnostic EP Catheter2Cleared 510(K)
- K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters2Cleared 510(K)
- K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter2Cleared 510(K)
- K160496Reprocessed Inquiry Steerable Diagnostic EP Catheter2Cleared 510(K)
- K160303Reprocessed Polaris X Steerable Diagnostic EP Catheter2Cleared 510(K)
- K160242Reprocessed Livewire Steerable Diagnostic EP Catheter2Cleared 510(K)
- K153153Reprocessed Electrophysiology Catheter2Cleared 510(K)
- K151617Livewire Electrophysiology Catheter2Cleared 510(K)
- K150357Reprocessed Electrophysiology Diagnostic Catheters2Cleared 510(K)
- K121158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS2Cleared 510(K)
- K112292REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K112232REPROCESSED ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K101789REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS2Cleared 510(K)
- K100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K092158REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS2Cleared 510(K)
- K090323REPROCESSED ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K082023REPROCESSED ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K081329REPROCESSED ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K061045REPROCESSED ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K052603REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K052414REPROCESSED ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K051220REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS2Cleared 510(K)
- K051043VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K050763VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K043392REPROCESSED ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K043393REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K040751VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K042074VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K043513STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER2Cleared 510(K)
- K030279REPROCESSED ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K030187REPROCESSED ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K030109ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K030026REPROCESSED ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K030114VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K023180VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K022316VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K012678REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS2Cleared 510(K)
- K012523REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS2Cleared 510(K)
- K012708ELECTROPHYSIOLOGY CATHETER2Cleared 510(K)
- K012687VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- K012688VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS2Cleared 510(K)
- 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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Reprocessed Polaris X Steerable Diagnostic EP Catheter
- Page Type
- Cleared 510(K)
- 510(k) Number
- K160303
- 510(k) Type
- Traditional
- Applicant
- Innovative Health, LLC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/10/2016
- Days to Decision
- 96 days
- Submission Type
- Summary