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510(k) Data Aggregation

    K Number
    K213200
    Device Name
    Solus Gold Embolization Device
    Date Cleared
    2022-03-21

    (173 days)

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

    Artio Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Solus Gold Embolization Device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
    Device Description
    The Solus Gold Embolization Device is a vascular plug device intended to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is comprised of an implant assembly and a delivery system assembly. The delivery system assembly is comprised of a microcatheter and a delivery catheter. A rotating hemostatic valve (RHV) and a 3-way stopcock is provided on the hub of the delivery catheter for injecting fluid to facilitate expansion of the implant. The Solus Gold implant is available in 3 mm – 6 mm diameters. All implant sizes are provided with the same delivery system, and the physician selects the device size based on the treatment plan. The Solus Gold implant assembly consists of a gold implant body, a distal neck subassembly, and an implant mating component. The proximal end of the implant is joined to the delivery catheter through the implant , which is a platinum tubular segment secured to the inside of the gold implant body with adhesive. The distal neck subassembly is comprised of two stacked silicone valves and a platinum (Pt) marker band that are contained within a stainless-steel housing and bonded to the implant with adhesive. The distal neck subassembly of the implant is mounted to the microcatheter over a preparation tool, which is removed by the user after device preparation. The implant is pleated and folded, loaded onto the delivery catheter and microcatheter, and protected with a sheath. The device is provided sterile and is intended for single use only.
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