BEUDAMED
    FDA Registration Active 🇺🇸 United States

    18G x 7cm (2.75 inch) Flashback 1-Part Introducer

    Reg #: 1835568 · FEI: 3001237677 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RLS Interventional Inc. DBA Inrad
    Registration Number
    1835568
    FEI Number
    3001237677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4375 Donkers Ct SE
    City
    Grand Rapids
    State
    MI
    ZIP
    49512
    Country
    US

    Regulatory Submissions

    510(k) Number
    K813019

    Owner / Operator

    Firm Name
    INRAD
    Operator Number
    9031756
    Address
    4375 DONKER COURT S.E., --
    City
    Grand Rapids
    State
    MI
    Postal Code
    49512
    Country
    US
    Correspondent
    Heidi - Halverson

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    18G x 7cm (2.75 inch) Flashback 1-Part Introducer 19G x 10cm (3.94 inch) Seldinger 2-Part Introducer 19G x 7cm (2.75 inch) Seldinger 2-Part Introducer 18G x 7cm (2.75 inch) Seldinger 2-Part Introducer 19G x 7cm (2.75 inch) Arterial 1-Part Introducer 19G x 7cm (2.75 inch) Flashback 1-Part Introducer 18G x 7cm (2.75 inch) Arterial 1-Part Introducer 18G x 7.3cm (2.875 inch) Seldinger 2-Part Introducer 22G x 14.9cm Chiba with 19G x 10cm Coaxial Needle 22G x 14.9cm Franseen with 19G x 10cm Coaxial Needle

    Establishment Types

    Manufacture Medical Device