BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AMS-494

    Reg #: 1223004 · FEI: 1000120555 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    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
    K011336

    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

    AMS-494 KS-975NF-2 AMS-490 KS-222-2 AMS-577-1 AMS-975-1 AMS-541 AMS-975FO AMS-998-1 BN-160 SS-933-1 AMS-122-1 AMS-492 KS-975-2 AMS-451 KS-122-2 AMS-570 AMS-565 AMS-532 AMS-295-1 AMS-292-2 AMS-934-1 AMS-975NF

    Establishment Types

    Manufacture Medical Device