BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Axium Prime Detachable Coil System

    Reg #: 3015550451 · FEI: 3015550451 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
    Registration Number
    3015550451
    FEI Number
    3015550451
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5290 California Avenue
    City
    Irvine
    State
    CA
    ZIP
    92617
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203432

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Device, Vascular, For Promoting Embolization KRD
    Device, Neurovascular Embolization HCG

    Proprietary Names

    Axium Prime Detachable Coil System Axium Detachable Coil System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility