BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Evolution(R) Shortie Mechanical Dilator Sheath Set

    Reg #: 2522007 · FEI: 2522007 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    COOK VANDERGRIFT INC.
    Registration Number
    2522007
    FEI Number
    2522007
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1186 Montgomery Lane
    City
    VANDERGRIFT
    State
    PA
    ZIP
    15690
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142301

    Owner / Operator

    Firm Name
    COOK VANDERGRIFT INC.
    Operator Number
    2522007
    Address
    1186 MONTGOMERY LANE, --
    City
    Vandergrift
    State
    PA
    Postal Code
    15690
    Country
    US
    Correspondent
    THOMAS J KARDOS

    Products

    Device Name Product Code
    Dilator, Vessel, For Percutaneous Catheterization DRE

    Proprietary Names

    Evolution(R) Shortie Mechanical Dilator Sheath Set Evolution(R) Mechanical Dilator Sheath Set SteadySheath(R) Evolution(R) Tissue Stabilization Sheath SteadySheath(R) Evolution(R) Shortie Tissue Stabilization Sheath

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device