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510(k) Data Aggregation

    K Number
    K170987
    Device Name
    Captus Vascular Retrieval System
    Manufacturer
    Avantec Vascular Corporation
    Date Cleared
    2017-08-28

    (147 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Avantec Vascular Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Captus Vascular Retrieval System is intended for use in the cardiovascular system to retrieve foreign objects, including, but not limited to guide wires, coils, balloons, catheters, and filters.
    Device Description
    The Captus Vascular Retrieval System consists of a flexible polyetheretherketone (PEEK) and Pebax shaft with a nitinol Braided Loop Snare (BLS) on the distal end. The device is designed to capture and retrieve foreign objects from the cardiovascular system. The lumen of the 120 cm long flexible snare shaft contains an inner rod that is secured to the BLS using an ultra-high molecular weight polyethylene (UHMWPE) braided suture. The external torquer is attached to the proximal end of the shaft and supports BLS manipulation. During the procedure, once the distal end has been positioned near the foreign object, the torquer can be turned clockwise (in relation to the shaft) in order to cinch the BLS. This feature allows the foreign object to be more firmly secured before its retrieval.
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