BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENROUTE Enflate Transcarotid RX Balloon Dilatation System

    Reg #: 3022627847 · FEI: 3022627847 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Silk Road Medical
    Registration Number
    3022627847
    FEI Number
    3022627847
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    14755 27th Avenue North
    City
    Plymouth
    State
    MN
    ZIP
    55447
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221414

    Owner / Operator

    Firm Name
    Boston Scientific Corporation
    Operator Number
    9912058
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Adrienne Bishop

    Products

    Device Name Product Code
    Catheter, Angioplasty, Peripheral, Transluminal LIT

    Proprietary Names

    ENROUTE Enflate Transcarotid RX Balloon Dilatation System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility