BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Boss Crossing Support Catheter

    Reg #: 3008110587 · FEI: 3008110587 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MARVAO MEDICAL DEVICES LTD.
    Registration Number
    3008110587
    FEI Number
    3008110587
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 1 Galway Business PArk, Dangan
    City
    Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K220632

    Owner / Operator

    Firm Name
    Marvao Medical Devices Ltd.
    Operator Number
    10039455
    Address
    Unit 1 Galway Business PArk, Dangan
    City
    Galway
    State
    IE-G
    Postal Code
    Galway
    Country
    IE

    US Agent

    Business Name
    Avania, LLC
    Contact Name
    Wanda Carpinella
    Address
    100 Crowley Drive
    City
    Marlboro
    State
    MA
    ZIP
    01752
    Country
    US
    Email
    [email protected]
    Phone
    781 7994572

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY

    Proprietary Names

    Boss Crossing Support Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility