BEUDAMED
    Product Code: OPR FDA class 3

    Intrasaccular Flow Disruption Device

    Unknown

    The Intrasaccular Flow Disruption Device (product code OPR) is a Class 3 neurovascular implantable device reviewed by the Neurology (NE) panel, requiring Premarket Approval (PMA) due to its high-risk indication. It is intended for the endovascular treatment of wide-neck intracranial aneurysms by being deployed within the aneurysm sac to disrupt blood flow and promote thrombosis, thereby reducing the risk of aneurysm rupture. The device is flagged as an implant and is not life-sustaining, and no regulation number has been assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

    Research product code OPR in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    OPR
    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

    An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.