BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

    Reg #: 3013300026 · FEI: 3013300026 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOSENSE WEBSTER, INC.
    Registration Number
    3013300026
    FEI Number
    3013300026
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170997

    Owner / Operator

    Firm Name
    BIOSENSE WEBSTER, INC.
    Operator Number
    9044811
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Maria Jose Arana

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath CARTO VIZIGO 8.5F Sheath with Curve Viz MdC, Short CARTO VIZIGO 8.5F Sheath with Curve Viz SmC, Short

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility