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510(k) Data Aggregation

    K Number
    K172390
    Device Name
    Optima Coil System
    Manufacturer
    Blockade Medical, LLC (d.b.a. Balt USA)
    Date Cleared
    2018-02-18

    (194 days)

    Product Code
    HCG, KRD
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    Blockade Medical, LLC (d.b.a. Balt USA)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
    Device Description
    The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded.
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