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
- K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter2Cleared 510(K)
- K250955XC11 ICE System, USA2Cleared 510(K)
- K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System2Cleared 510(K)
- K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™2Cleared 510(K)
- K251231ViewFlex™ X ICE Catheter, Sensor Enabled™2Cleared 510(K)
- K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)2Cleared 510(K)
- K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System2Cleared 510(K)
- K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter2Cleared 510(K)
- K240050SOUNDSTAR™ CRYSTAL Ultrasound Catheter2Cleared 510(K)
- K233948Provisio™ SLT IVUS™ System2Cleared 510(K)
- K233270AcuNav Crystal Ultrasound Catheter2Cleared 510(K)
- K230453OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter2Cleared 510(K)
- K223766NUVISION™ NAV Ultrasound Catheter2Cleared 510(K)
- K223077ViewFlex Xtra ICE Catheter2Cleared 510(K)
- K222568OptiCross™ 18 Peripheral Imaging Catheter2Cleared 510(K)
- K213593OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD2Cleared 510(K)
- K212959ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter2Cleared 510(K)
- K201775NuVision ICE Catheter2Cleared 510(K)
- K203726ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter2Cleared 510(K)
- K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter2Cleared 510(K)
- K200195NES Reprocessed Visions PV .014P RX Digital IVUS Catheter2Cleared 510(K)
- K200410Reconnaissance PV .018 OTW Digital IVUS Catheter2Cleared 510(K)
- K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter2Cleared 510(K)
- K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System2Cleared 510(K)
- K172258Novasight Hybrid System2Cleared 510(K)
- K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)2Cleared 510(K)
- K173618ACUSON AcuNav Volume Intracardiac Echocardiography Catheter2Cleared 510(K)
- K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)2Cleared 510(K)
- K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System2Cleared 510(K)
- K170992AcuNav V 10F Ultrasound Catheter2Cleared 510(K)
- K170263AcuNav Diagnostic Ultrasound Catheter 8F,10F2Cleared 510(K)
- K163478AcuNav Volume ICE Catheter2Cleared 510(K)
- K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip2Cleared 510(K)
- K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter2Cleared 510(K)
- K161125OptiCross X, 40 MHz Coronary Imaging Catheter2Cleared 510(K)
- K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)2Cleared 510(K)
- K153094Visions PV .035 Digital IVUS Catheter2Cleared 510(K)
- K152829Visions PV.014P RX Digital IVUS Catheter2Cleared 510(K)
- K150442Volcano Visions PV .018 Digital IVUS Catheter2Cleared 510(K)
- K143701EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM2Cleared 510(K)
- K141618ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS2Cleared 510(K)
- K133853VIEWFLEX XTRA ICE CATHETER2Cleared 510(K)
- K140318SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER2Cleared 510(K)
- K132133CG+ ARROW JACC POWERED BY ARROW VPS STYLET2Cleared 510(K)
- K123621OPTICROSS 40 MHZ CORONARY IMAGING CATHETER2Cleared 510(K)
- K123813VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE2Cleared 510(K)
- K122878HD-IVUS ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K121273VISIONS PV .035 DITITAL IVUS CATHETER2Cleared 510(K)
- K113008KODAMA INTRAVASCULAR ULRASOUND CATHETER2Cleared 510(K)
- K120697EAGLE EYE PLATINUM ST CATHETER2Cleared 510(K)
- K112050SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER2Cleared 510(K)
- K111043ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER2Cleared 510(K)
- K103260VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE2Cleared 510(K)
- K103255VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET2Cleared 510(K)
- K101138SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-122Cleared 510(K)
- K092596EAGLE EYE PLATINUM DIGITAL IVUS CATHETER2Cleared 510(K)
- K091352SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-052Cleared 510(K)
- K092064SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-122Cleared 510(K)
- K081626FLOWPICC CONSOLE2Cleared 510(K)
- K081808ACUNAV V ULTRASOUND CATHETER2Cleared 510(K)
- K081625FLOWPICC STYLET2Cleared 510(K)
- K080891REVOLUTION 45MHZ IVUS IMAGING CATHETER2Cleared 510(K)
- K073473EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 857002Cleared 510(K)
- K071554VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM2Cleared 510(K)
- K071660VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 889002Cleared 510(K)
- K071234ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F2Cleared 510(K)
- K070242SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-052Cleared 510(K)
- K051337EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-0012Cleared 510(K)
- K051679ILAB ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K050995REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER2Cleared 510(K)
- K042593ACUSON ACUNAV 8F ULTRASOUND CATHETER2Cleared 510(K)
- K041727MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 364562Cleared 510(K)
- K041134COMBOMAP PRESSURE AND FLOW SYSTEM2Cleared 510(K)
- K033650ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER2Cleared 510(K)
- K031346JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 859002Cleared 510(K)
- K030524CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN2Cleared 510(K)
- 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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ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K191175
- 510(k) Type
- Traditional
- Applicant
- ACIST Medical Systems, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/27/2019
- Days to Decision
- 57 days
- Submission Type
- Summary