BEUDAMED
    FDA Registration Active 🇺🇸 United States

    q50 plus stent graft balloon catheter18

    Reg #: 3008627763 · FEI: 3008627763 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    I-Tek Medical, Inc.
    Registration Number
    3008627763
    FEI Number
    3008627763
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1837 Buerkle Rd
    City
    White Bear Lake
    State
    MN
    ZIP
    55110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120381

    Owner / Operator

    Firm Name
    I-Tek Medical, Inc.
    Operator Number
    10047604
    Address
    1837 Buerkle Road
    City
    White Bear Lake
    State
    MN
    Postal Code
    55110
    Country
    US
    Correspondent
    Patrick Haley

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY
    Catheter, Intravascular Occluding, Temporary MJN

    Proprietary Names

    q50 plus stent graft balloon catheter18

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)