BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sublime™ Radial Access Guide Sheath

    Reg #: 3001374820 · FEI: 3001374820 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SURMODICS, INC.
    Registration Number
    3001374820
    FEI Number
    3001374820
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9924 W 74th St
    City
    EDEN PRAIRIE
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190644

    Owner / Operator

    Firm Name
    SURMODICS, INC.
    Operator Number
    9070604
    Address
    9924 WEST 74TH STREET, --
    City
    Eden Prairie
    State
    MN
    Postal Code
    55344
    Country
    US
    Correspondent
    SHAWN K FULLER

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    Sublime™ Radial Access Guide Sheath

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility