BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHY-1915

    Reg #: 1223004 · FEI: 1000120555 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    36
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Vygon MFG
    Registration Number
    1223004
    FEI Number
    1000120555
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    87 Venture Dr
    City
    DOVER
    State
    NH
    ZIP
    03820
    Country
    US

    Regulatory Submissions

    510(k) Number
    K020544

    Owner / Operator

    Firm Name
    VYGON USA
    Operator Number
    2245270
    Address
    2750 Morris Road, Suite A200
    City
    Lansdale
    State
    PA
    Postal Code
    19446
    Country
    US
    Correspondent
    Chris Steinke

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA

    Proprietary Names

    SHY-1915 SHY-2034 SHY-2210 SHY-2250 SHS-2210 SHS-2010 SHY-2015 SHS-1910 BHS-2250 BHS-2010 BHY-2250 BHS-2210 BHY-1910 BHS-2015 BHY-2210 BHS-2234 BHY-2015 BHS-1910 BHS-2034 BHY-1915 BHY-2010 BHY-2234 BHY-2034 SHS-2210-1 SHY-2034-1 SHS-2010-1 SHS-2234-1 SHY-2010-1 SHS-2034-1 SHS-2234 SHS-2250 SHY-2010 SHY-2234 SHY-1910 SHS-2034 SHS-2015

    Establishment Types

    Manufacture Medical Device