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
- 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
- K243944Aperta NSE PTA Balloon Dilatation Catheter2Cleared 510(K)
- K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter2Cleared 510(K)
- K241478Tri-Wedge PTA Scoring Balloon Dilatation Catheter2Cleared 510(K)
- K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter2Cleared 510(K)
- K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)2Cleared 510(K)
- K232207D·Kutting™ PTA Scoring Balloon Dilatation Catheter2Cleared 510(K)
- K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter2Cleared 510(K)
- K220704Serranator PTA Serration Balloon Catheter2Cleared 510(K)
- K213728Serranator PTA Serration Balloon Catheter2Cleared 510(K)
- K203437Serranator PTA Serration Balloon Catheter2Cleared 510(K)
- K202187FLEX Vessel Prep System2Cleared 510(K)
- K193495XO Score Percutaneous Transluminal Angioplasty Scoring Catheter2Cleared 510(K)
- K193181Serranator PTA Serration Balloon Catheter2Cleared 510(K)
- K182713Scoreflex PTA Scoring Balloon Catheter2Cleared 510(K)
- K172571ULTRASCORE Focused Force PTA Balloon2Cleared 510(K)
- K163420UltraScore Focused Force PTA Balloon2Cleared 510(K)
- K163380Serranator Alto PTA Serration Balloon Catheter2Cleared 510(K)
- K152789FLEX SCORING CATHETER2Cleared 510(K)
- K1512532cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter2Cleared 510(K)
- K150634AngioSculpt PTA Scoring Baloon Catheters2Cleared 510(K)
- K141322ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER2Cleared 510(K)
- K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating2Cleared 510(K)
- K133998ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING2Cleared 510(K)
- K122685ANGIOSCULPT PTA SCORING BALLOON CATHETER2Cleared 510(K)
- K113103SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE2Cleared 510(K)
- K112182ANGIOSCULPT PTA SCORING BALLOON CATHETER2Cleared 510(K)
- K110767ANGIOSCULPT PTA SCORING BALLOON CATHETER2Cleared 510(K)
- K103459VASCUTRAK PTA DILATATION CATHETER2Cleared 510(K)
- K101735ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY2Cleared 510(K)
- K100303ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY2Cleared 510(K)
- K091966ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-60402Cleared 510(K)
- K082343VASCUTRAK 2, MODELS: V14 AND V182Cleared 510(K)
- K082059ANGIOSCULPT PTA SCORING BALLOON CATHETER2Cleared 510(K)
- K081220MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER2Cleared 510(K)
- K080151ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 20392Cleared 510(K)
- K073025VASCUTRAK II PTA DILATATION CATHETER2Cleared 510(K)
- K072225ANGIOSCULPT PTA SCORING BALLOON CATHETER2Cleared 510(K)
- K0709512CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS2Cleared 510(K)
- K063657VASCUTRAK PTA DILATION CATHETER2Cleared 510(K)
- K062387SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM2Cleared 510(K)
- K050629ANGIOSCULPT SCORING BALLOON CATHETER2Cleared 510(K)
- K051254PERIPHERAL CUTTING BALLOON2Cleared 510(K)
- K0419932 CM PERIPHERAL CUTTING BALOON2Cleared 510(K)
- K040155PERIPHERAL CUTTING BALLOON2Cleared 510(K)
- 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
- 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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SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K113103
- 510(k) Type
- Traditional
- Applicant
- REX MEDICAL
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/22/2012
- Days to Decision
- 216 days
- Submission Type
- Summary