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510(k) Data Aggregation

    K Number
    K182944
    Device Name
    Dr. Amplatz Micro Plug
    Manufacturer
    KA Medical, LLC
    Date Cleared
    2019-04-17

    (176 days)

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

    KA Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dr. Amplatz Micro Plug is indicated for arterial embolization in the peripheral vasculature.
    Device Description
    The Dr. Amplatz Micro Plug includes the Micro Plug Device which is a self-expanding braided Nitinol vascular occlusion implant that is supplied with components used for implantation. The Micro Plug Device has been designed with a material, size, configuration and shape that allows introduction through a catheter for the occlusion of blood vessels in the peripheral vasculature. The Micro Plug Devices are provided in four different diameters (3 mm - 6 mm) to treat different sized blood vessels in the peripheral vasculature. The Micro Plug Device has radiopaque marker bands attached to each end and a screw attachment for connection to a Delivery Wire. The Micro Plug Device is packaged collapsed within a Loader and attached to a 180 cm Delivery Wire that is provided within a hoop dispenser. The delivery system includes a 125 cm Delivery Catheter that is provided within a hoop dispenser for delivery and implantation of the Device; the Delivery Catheter contains a standard luer hub adapter at the proximal end and a single radiopaque marker band at the distal end. The Delivery Catheter is hydrophilic coated. Tuohy Borst Valves are provided for flushing; a Torque Device is provided for releasing the Device. The Dr. Amplatz Micro Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature by physicians trained in vascular embolization.
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