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
- K253616ProtekDilate Vascular Access Kit2Cleared 510(K)
- K251325VersaCross Connect™ Transseptal Dilator2Cleared 510(K)
- K242229Micro Ace Gold Advanced Micro Access System2Cleared 510(K)
- K241720VersaCross Connect™ Transseptal Dilator2Cleared 510(K)
- K233647VersaCross Connect™ Transseptal Dilator2Cleared 510(K)
- K232609Micro Ace™ Advanced Micro Access System2Cleared 510(K)
- K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)2Cleared 510(K)
- K212784TightRail Guardian Motorized Dilator Sheath2Cleared 510(K)
- K211679Xtractor device2Cleared 510(K)
- K210734Endovascular Dilator and Sets2Cleared 510(K)
- K201288ExpanSure Large Access Transseptal Dilator2Cleared 510(K)
- K192283MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator2Cleared 510(K)
- K200379Super Sheath2Cleared 510(K)
- K192195Sterile Dilator2Cleared 510(K)
- K190175S-MAK XL2Cleared 510(K)
- K182064ExpanSure Transseptal Dilation System2Cleared 510(K)
- K183036Dilator Sets2Cleared 510(K)
- K182914MC3 Vascular Access Kit 210302Cleared 510(K)
- K172487Coaxial Dilator Set (Micro-Introducer)2Cleared 510(K)
- K162389Medcomp Vessel Dilator2Cleared 510(K)
- K170616van Andel Dilatation Catheter2Cleared 510(K)
- K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set2Cleared 510(K)
- K161336VSI StraitSet micro-introducer kit2Cleared 510(K)
- K150932Sheath Introducer2Cleared 510(K)
- K161333TightRail Sub-C Rotating Dilator Sheath2Cleared 510(K)
- K151877MicroTract Access System2Cleared 510(K)
- K151076MicroTaper Needle Introducer Set2Cleared 510(K)
- K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath2Cleared 510(K)
- K141070SUPER SHEATH2Cleared 510(K)
- K142301Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath2Cleared 510(K)
- K142546TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath2Cleared 510(K)
- K141148EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET2Cleared 510(K)
- K141131TIGHTRAIL MINI2Cleared 510(K)
- K140047LEXICONTURE MECHANICAL DILATOR SHEATH SET2Cleared 510(K)
- K133631LEXIPLIANT DILATOR SHEATH SET2Cleared 510(K)
- K132713NMI COAXIAL MICROINTRODUCER SET2Cleared 510(K)
- K123842LAWMAX DILATOR2Cleared 510(K)
- K130791PRELUDE SHEATH INTRODUCER2Cleared 510(K)
- K123445NMI COAXIAL MICROINTRODUCER SET2Cleared 510(K)
- K120349SONIXGPS VASCULAR ACCESS NEEDLE KIT2Cleared 510(K)
- K103421ARSTASIS DILATOR ADAPTER2Cleared 510(K)
- K093554RETROFLEX DILATOR KIT2Cleared 510(K)
- K092378SPECTRANETICS VISISHEATH DILATOR SHEATH2Cleared 510(K)
- K091584MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE2Cleared 510(K)
- K081940AVALON ELITE VASCULAR ACCESS KIT2Cleared 510(K)
- K082075HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER2Cleared 510(K)
- K073035PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS2Cleared 510(K)
- K071330GALTSTICK INTRODUCER SYSTEM2Cleared 510(K)
- K070749ESTECH PERCUTANEOUS INSERTION DILATOR KIT2Cleared 510(K)
- K070159PRELUDE SHEATH INTRODUCER2Cleared 510(K)
- K062554STARCLOSE HEX-HUB DILATOR2Cleared 510(K)
- K061000EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.02Cleared 510(K)
- K052557SUPER SHEATH INTRODUCER SHEATH2Cleared 510(K)
- K050962MERIT PRELUDE SHEATH INTRODUCER2Cleared 510(K)
- K031691MERIT MAK (MINI ACCESS KIT)2Cleared 510(K)
- K030260GELBFISH FLEX VASCULAR DILATOR2Cleared 510(K)
- K023507MODIFICATION TO GELBFISH VASCULAR DILATORS2Cleared 510(K)
- K012256GELBISH VASCULAR DILATOR2Cleared 510(K)
- K010055COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH2Cleared 510(K)
- K000737COAXIAL DILATOR SET2Cleared 510(K)
- K974617PERIPHERAL VASCULAR DILATOR2Cleared 510(K)
- K980282URESIL DILATOR WITH RADIOPAQUE MARKER2Cleared 510(K)
- K974640COAXIAL DILATOR SET2Cleared 510(K)
- K970470EVT EXPANDABLE SHEATH2Cleared 510(K)
- K970392CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM2Cleared 510(K)
- K945586FLEXIBLE DILATING SHEATH2Cleared 510(K)
- K963388VESSEL DILATOR2Cleared 510(K)
- K960917PERCUGLIDE2Cleared 510(K)
- K914555WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)2Cleared 510(K)
- K913027VESSEL DILATOR2Cleared 510(K)
- K912050NOVOSTE VESSEL DILATER2Cleared 510(K)
- K905416VESSEL DILATOR2Cleared 510(K)
- K904476VESSEL DILATOR2Cleared 510(K)
- K902469BYRD DILATOR SHEATH SET - TEFLON2Cleared 510(K)
- K901815MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY2Cleared 510(K)
- K896096SOLOSTICK (AMPLATZ DILATOR NEEDLE)2Cleared 510(K)
- K894330DAIG VESSEL DILATOR2Cleared 510(K)
- K882238VESSEL DILATOR AND INTRODUCER SHEATH2Cleared 510(K)
- K881073SHILEY FEMORAL CANNULAE INTRODUCER KIT2Cleared 510(K)
- K87473810 AND 12 FRENCH VESSEL DILATORS2Cleared 510(K)
- K875327MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT2Cleared 510(K)
- K872724SHEATH/DILATORS2Cleared 510(K)
- K870413PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)2Cleared 510(K)
- K871148URESIL CAROTID ARTERY SIZERS2Cleared 510(K)
- K862288MODIFICATION OF TISSUE DILATOR2Cleared 510(K)
- K860161HEART CATHETERIZATION TRAY2Cleared 510(K)
- K850337CARDIAC CATHETERIZATION PACK2Cleared 510(K)
- K843261ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD2Cleared 510(K)
- K842113AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT2Cleared 510(K)
- K84199510.5 FRENCH DILATOR, 15CM, W/LUER LOCK2Cleared 510(K)
- K840671CARDIAC CATHETERIZATION PACK2Cleared 510(K)
- K840022HEART CATHETERIZATION TRAY SET2Cleared 510(K)
- K840017VERTEX PERCUTANEOUS CATHETER INTRODUC2Cleared 510(K)
- K8339658 FRENCH DILATOR 15CM, W/LUER LOCK2Cleared 510(K)
- K831190VESSEL DILATOR2Cleared 510(K)
- K822595VESSEL DILATOR2Cleared 510(K)
- K813461PERCUTANEOUS ENTRY NEEDLE, SELDINGER2Cleared 510(K)
- K813125MICRO TRANSDUCER CATHETERS2Cleared 510(K)
- K810859SINGLE USE SELDINGER/COURNAND PERC. NDL2Cleared 510(K)
- K802327SHEATH DILATOR SET2Cleared 510(K)
- K801113DILATOR, VESSEL, FOR PERC. CATHETER.2Cleared 510(K)
- K800462PERCUTANEOUS INTRODUCER SET2Cleared 510(K)
- K780126DILATOR, VESSEL & INTRODUCER, SHEATH2Cleared 510(K)
- K760403TEMPORARY ATRIAL ELECTRODE KIT2Cleared 510(K)
- 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
- 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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TightRail Sub-C Rotating Dilator Sheath
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K161333
- 510(k) Type
- Traditional
- Applicant
- Spectranetics, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/8/2016
- Days to Decision
- 57 days
- Submission Type
- Summary