BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACIST MEDICAL SYSTEMS, INC.

    Reg #: 2134243 · FEI: 3001726808 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    44
    Establishment Types
    5
    Classifications
    9

    Registration Details

    Registration Name
    ACIST MEDICAL SYSTEMS, INC.
    Registration Number
    2134243
    FEI Number
    3001726808
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    7905 FULLER ROAD
    City
    EDEN PRAIRIE
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233904

    Owner / Operator

    Firm Name
    ACIST MEDICAL SYSTEMS, INC.
    Operator Number
    9028115
    Address
    7905 FULLER RD., --
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    Milana Solganik

    Products

    Device Name Product Code
    Catheter, Pressure Monitoring, Cardiac OBI
    Transducer, Pressure, Catheter Tip DXO
    Plethysmograph, Impedance DSB
    Injector, Contrast Medium, Automatic IZQ
    System, X-Ray, Tomography, Computed JAK
    Injector And Syringe, Angiographic DXT
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Catheter, Ultrasound, Intravascular OBJ
    Amplifier And Signal Conditioner, Transducer Signal DRQ

    Proprietary Names

    ACIST Rapid Exchange System (RXi)_dPR and Navvus II MicroCatheter EmpowerCTA Injector System (Empower Sync Remote) Rapid Exchange (RXi) System Navvus Catheter ACIST CVi®1 Contrast Delivery System A1000V Syringe Kit VeraPro AngioTouch HiFi 165 VeraPro AngioTouch FLX 165 VeraPro S100 VeraPro S100 LV1 VeraPro AMT ACIST Rapid Exchange System (RXi) and Navvus II MicroCatheter Fastload MR Syringe Pack, EmpowerMR Injector System ACIST HDi® System ACIST Kodama® Intravascular Ultrasound Catheter ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System A2000 Multi-use Syringe Kit, A2000V Multi-use Syringe Kit, B/BT2000 Automated Manifold Kit CVI INJECTION SYSTEM CMS2000 ACIST CVi® BT2000 Manifold Kit ACIST CVi® AngioTouch® Kit AT P65 ACIST CVi® A2000 Syringe Kit ACIST CVi® AngioTouch® Kit AT P54 ACIST CVi® Contrast Delivery System CT Expres 3D Contrast Media Delivery System Day Set III HP Bottle Spike Patient Set AngioTouch Handcontroller Kits (Models ATP54, ATP65, ATR54, ATL65) ACIST RXi Mini System and Accessories ACIST Rapid Exchange (RXi) System with dPR Triple Transducer Cable ACIST Pro Cart ACIST Pro™ Diagnostic System AngioTouch Module Processing Unit Bed Mount Single Transducer Cable EmpowerCTA/EmpowerCTA+ CPT2000 Automated Manifold Kit EmpowerCTA+ Injector System ACIST HDi System AT X65L AngioTouch Kit AT X65 AngioTouch Kit ACIST CVi®1 Contrast Delivery System; ACIST CVi® Contrast Delivery System

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Device in the United States for Export Only