BEUDAMED
    Product Code: OBA

    Polymerizing, Neurovascular Embolization Material

    Unknown

    The Polymerizing, Neurovascular Embolization Material (product code OBA) is an implantable liquid embolic agent that polymerizes or precipitates in situ within a blood vessel to permanently obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device class is designated "f" indicating de novo classification, reviewed by the Neurology panel. This device carries both implant and life-sustaining flags, reflecting its permanent implantation and its critical role in treating life-threatening neurovascular conditions.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Basic Information

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

    Device Characteristics

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

    Definition

    The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ.

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.