BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lyka PORT Needle Free Access Device

    Reg #: 1000324175 · FEI: 1000324175 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Halkey-Roberts Corporation
    Registration Number
    1000324175
    FEI Number
    1000324175
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2700 Halkey-Roberts Place North
    City
    Saint Petersburg
    State
    FL
    ZIP
    33716
    Country
    US

    Regulatory Submissions

    510(k) Number
    K241058

    Owner / Operator

    Firm Name
    ATRION CORP.
    Operator Number
    9914015
    Address
    ONE ALLENTOWN PKWY., --
    City
    Allen
    State
    TX
    Postal Code
    75002
    Country
    US

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    Lyka PORT Needle Free Access Device

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)