BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AuST Steerable Sheath

    Reg #: 3015970743 · FEI: 3015970743 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CENTERPOINT SYSTEMS LLC
    Registration Number
    3015970743
    FEI Number
    3015970743
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3338 Parkway Blvd.
    City
    West Valley City
    State
    UT
    ZIP
    84119
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242106

    Owner / Operator

    Firm Name
    CenterPoint Systems LLC
    Operator Number
    10061099
    Address
    3338 PARKWAY BLVD
    City
    West Valley City
    State
    UT
    Postal Code
    84119
    Country
    US
    Correspondent
    Conner Johnson

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Catheter, Steerable DRA

    Proprietary Names

    AuST Steerable Sheath

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198