BEUDAMED
    Product Code: OUT FDA class 3

    Intracranial Aneurysm Flow Diverter

    Unknown

    The Intracranial Aneurysm Flow Diverter (product code OUT) is an implantable neurovascular device used for the treatment of wide-necked and larger or giant intracranial aneurysms. It is a stent-like device deployed within the parent artery to divert blood flow away from the aneurysm sac, promoting thrombosis and aneurysm occlusion. As an FDA Class 3 device without an assigned regulation number, it requires Premarket Approval (PMA) to demonstrate safety and effectiveness, and is reviewed by the Neurology panel. The device is flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    OUT
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    2

    Device Characteristics

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

    Definition

    Treatment of wide-necked and larger or giant intracranial aneurysms.

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.