BEUDAMED
    FDA Registration Active 🇺🇸 United States

    087 Balloon Guide Catheter System

    Reg #: 3020954126 · FEI: 3020954126 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Q'apel Medical, Inc.
    Registration Number
    3020954126
    FEI Number
    3020954126
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4245 Technology Drive
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190749

    Owner / Operator

    Firm Name
    Q'Apel Medical Inc.
    Operator Number
    10058467
    Address
    4245 Technology Drive
    City
    Fremont
    State
    CA
    Postal Code
    94538
    Country
    US
    Correspondent
    Jennifer Mateus

    Products

    Device Name Product Code
    Catheter, Percutaneous DQY

    Proprietary Names

    087 Balloon Guide Catheter System Walrus

    Establishment Types

    Manufacture Medical Device