BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AMS-546-2

    Reg #: 2245270 · FEI: 2245270 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VYGON USA
    Registration Number
    2245270
    FEI Number
    2245270
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2750 Morris Rd Suite A200
    City
    Lansdale
    State
    PA
    ZIP
    19446
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021395

    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-546-2 AMS-887-4 AMS-176 SS-461 AMS-944 SS-885-2 AMS-945 AMS-884-2T AMS-467 AMS-519-1 CMS-608 AMS-467C AMS-485-1 BN-762 AMS-803 AMS-542 AMS-540-1 AMS-375 AMS-483C

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility