BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    ACIST Kodama® Intravascular Ultrasound Catheter

    Reg #: 3009537152 · FEI: 3009537152 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    FUJIKURA FIBER OPTICS VIETNAM LTD
    Registration Number
    3009537152
    FEI Number
    3009537152
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 9 , Street 6, VSIP, Binh Hoa Ward,
    City
    Thuan An Binh Duong
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K193183

    Owner / Operator

    Firm Name
    Fujikura Fiber Optics VietNam Ltd
    Operator Number
    10044715
    Address
    No 9 , street 6, VSIP, Binh Hoa ward
    City
    Thuan An
    State
    Binh Duong
    Postal Code
    72000
    Country
    VN

    US Agent

    Business Name
    ACIST Medical Systems, Inc.
    Contact Name
    Carl Bracken -
    Address
    7905 FULLER RD
    City
    EDEN PRAIRIE
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    952 2534566

    Products

    Device Name Product Code
    Catheter, Ultrasound, Intravascular OBJ

    Proprietary Names

    ACIST Kodama® Intravascular Ultrasound Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)