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510(k) Data Aggregation

    K Number
    K132545
    Device Name
    MEDIVALVE ACWIRE
    Manufacturer
    Date Cleared
    2013-11-08

    (87 days)

    Product Code
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIVALVE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ac Wire is intended for use in peripheral vascular and heart catheterization procedures to introduce and assist in positioning diagnostic and interventional devices. The ac Wire may also function as an alignment tool by providing a reference plane of anatomical structures of interest (e.g., the aortic valve).
    Device Description
    The ac Wire device is a 0.035"" outside diameter, single use, disposable guidewire. The ac Wire device consists of a flexible guidewire that incorporates a low profile, radiopaque alignment element consisting of three loops with radiopaque markers that when open, form a "tulip" configuration designed to assist the physician in acquiring a reference plane under fluoroscopy.
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