BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    OPN NC PTCA balloon

    Reg #: 3024893679 · FEI: 3024893679 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ates Distribution
    Registration Number
    3024893679
    FEI Number
    3024893679
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3165 rue Star
    City
    Saint-Hubert Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K212393

    Owner / Operator

    Firm Name
    Ates Medical
    Operator Number
    10086840
    Address
    3165 rue Star
    City
    Saint-Hubert
    State
    Quebec
    Postal Code
    J3Y 3W5
    Country
    CA
    Correspondent
    Guy Belanger

    Products

    Device Name Product Code
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX

    Proprietary Names

    OPN NC PTCA balloon

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device