BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Axium Detachable Coil; Axium Prime Detachable Coil

    K Number: K203432 · Decision Jul 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    32
    Review Days
    226

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    Basic Information

    Device Name
    Axium Detachable Coil; Axium Prime Detachable Coil
    K Number
    K203432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
    Date Received
    November 23, 2020
    Decision Date
    July 7, 2021
    Product Code
    HCG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HCG Device, Neurovascular Embolization

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