BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Biowy PICC-S Kit

    Reg #: 3013233645 · FEI: 3013233645 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    BIOWY CORPORATION
    Registration Number
    3013233645
    FEI Number
    3013233645
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    27031 Vista Terrace
    City
    Lake Forest
    State
    CA
    ZIP
    92630
    Country
    US

    Regulatory Submissions

    510(k) Number
    K192246

    Owner / Operator

    Firm Name
    Biowy Corporation
    Operator Number
    10057786
    Address
    27031 Vista Terrace, 27002 Vista Terrace
    City
    Lake Forest
    State
    CA
    Postal Code
    92630
    Country
    US
    Correspondent
    Zhihua - Lu

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS

    Proprietary Names

    Biowy PICC-S Kit

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only