Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K220699
    Device Name
    Prestige Coil System
    Manufacturer
    Bait USA, LLC
    Date Cleared
    2022-04-08

    (29 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bait USA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prestige Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
    Device Description
    The Prestige Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize peripheral 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 anomalies to create blood stasis, reducing flow in the target vasculature, and inducing thrombosis. Upon positioning coils into the vasculature, the coils are thermally detached from the delivery pusher in serial manner until the target vasculature is occluded.
    Ask a Question

    Page 1 of 1