Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K112674
    Device Name
    NAVIS TORQUER
    Manufacturer
    Date Cleared
    2012-07-06

    (296 days)

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

    NAVIS MEDICAL,INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Navis Torquer is intended to facilitate guide wire manipulation during interventional procedures.
    Device Description
    The Navis Torquer is a guide wire accessory intended to assist with the manipulation and placement of guide wires during interventional procedures. It accommodates guide wires with diameters from 0.010 to 0.038 inches and is composed of the following two components: 1) a polycarbonate cylindrical body and collet; and 2) an acetal rotatable cap. The side-entry design of the device allows single-handed operation. To mount the device on a guide wire, the cylinder body is rotated into the cap until a tactile 'click' is felt and the longitudinal slots in both parts are aligned, the device is then mounted on the guide wire. Holding the guide wire stationary, the device is rotated onto the guide wire until the guide wire is aligned within the center of the device. The device is positioned optimally on the guide wire and then secured by rotation of the cap or cylinder body. As the cap is rotated on the body, the collet grips the guide wire.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1