BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    AcQRef Introducer Sheath

    Reg #: 3011752740 · FEI: 3011752740 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AGILE MV
    Registration Number
    3011752740
    FEI Number
    3011752740
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3700 rue Saint-Patrick, suite 102
    City
    Montreal Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K171557

    Owner / Operator

    Firm Name
    Resonetics, LLC
    Operator Number
    10078190
    Address
    26 Whipple Street
    City
    Nashua
    State
    NH
    Postal Code
    03060
    Country
    US
    Correspondent
    Jamie L Vaillancourt

    US Agent

    Business Name
    RESONETICS, LLC
    Contact Name
    Jamie Vaillancourt
    Address
    26 Whipple Street
    City
    Nashua
    State
    NH
    ZIP
    03060
    Country
    US
    Email
    [email protected]
    Phone
    603 8866772

    Products

    Device Name Product Code
    Introducer, Catheter DYB

    Proprietary Names

    AcQRef Introducer Sheath

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)