BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

    Reg #: 2134243 · FEI: 3001726808 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ACIST MEDICAL SYSTEMS, INC.
    Registration Number
    2134243
    FEI Number
    3001726808
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7905 FULLER ROAD
    City
    EDEN PRAIRIE
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191175

    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, Ultrasound, Intravascular OBJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device