BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pounce™ Sheath

    Reg #: 3014687026 · FEI: 3014687026 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    SURMODICS, INC.
    Registration Number
    3014687026
    FEI Number
    3014687026
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7905 Golden Triangle Drive Suite 190
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231828

    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

    Pounce™ Sheath

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198