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510(k) Data Aggregation

    K Number
    K032896
    Device Name
    ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02
    Manufacturer
    Date Cleared
    2004-03-17

    (182 days)

    Product Code
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ANSON MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Anson Refix tissue and vascular clip is intended: - To assist in the creation of anastomoses in blood vessels, grafts, and, . - For the surgical approximation of tissue to tissue, or tissue to woven graft . material for general and vascular surgery.
    Device Description
    The Refix tissue and vascular clip consists of an implantable clip and a delivery system. The Anson Refix Clip is comprised of a single monofilament, Nitinol wire, which is sharpened at both ends. The arms of the device are curved as in a bow and are separated via a loop of wire in the center.
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