BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Shockwave S4 IV Lithotripsy (IVL) Catheter, Medical Peripheral IV Lithotripsy System, IVL Generator and Connector Cable

    Reg #: 3004363082 · FEI: 3004363082 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VANGUARD-EMS
    Registration Number
    3004363082
    FEI Number
    3004363082
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3725 SW Hocken Ave
    City
    BEAVERTON
    State
    OR
    ZIP
    97005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191840

    Owner / Operator

    Firm Name
    Vanguard EMS, Inc.
    Operator Number
    9059001
    Address
    3725 SW Hocken Ave., --
    City
    Beaverton
    State
    OR
    Postal Code
    97005
    Country
    US
    Correspondent
    Amanda Musser

    Products

    Device Name Product Code
    Percutaneous Catheter, Ultrasound PPN

    Proprietary Names

    Shockwave S4 IV Lithotripsy (IVL) Catheter, Medical Peripheral IV Lithotripsy System, IVL Generator and Connector Cable

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)