BEUDAMED
    Product Code: OUU

    Polymeric Neurovascular Embolization

    Unknown

    The Polymeric Neurovascular Embolization device (product code OUU) is a neurovascular implant used for the treatment of intracranial aneurysms through endovascular embolization. It employs a polymeric material delivered endovascularly to occlude the aneurysm and prevent rupture. This device does not have a standard FDA device class assignment (listed as class "f"), indicating it underwent a special regulatory pathway such as a humanitarian device exemption or similar mechanism. It is reviewed by the Neurology panel and is flagged as an implant. It is not flagged as life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    OUU
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    6

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Treatment of intracranial aneurysms