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510(k) Data Aggregation

    K Number
    K141054
    Device Name
    DISTAL ACCESS TORQUE DEVICE
    Manufacturer
    DISTAL ACCESS, LLC
    Date Cleared
    2014-12-10

    (236 days)

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

    DISTAL ACCESS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Distal Access torque devices are used to maneuver quide wires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature.
    Device Description
    The Distal Access Torque Device (Predict / Spinr Controller) is a single-use hand-held manually operated high-performance torque device / controller used to maneuver difficult-to-grasp devices including quidewires during interventional or diagnostic procedures. The Predict's design allows for predictable and controllable rotation of a device clockwise with counterclockwise return to its original orientation. Clockwise and counterclockwise rotations are manually controlled so the Predict rotates the same number of rotations in one direction as the other. Similar to the predicates, the user manually advances and retracts the Predict torque device forward and backward to introduce or remove the connected device from the body. Also, identical to the predicates, the Predict may be connected to a device already in the body. Same as the predicates, a device, including a guidewire, is loaded into the Predict 0.014 - 0.039" by inserting the proximal end of the device into the distal end of the Predict's cap. The Predict locks down on the device when the user rotates the collet cap clockwise, forcing the industry standard designed collet to grip onto the device is released when the user rotates the cap counterclockwise to loosen the collet's grip on the device. Once a device is connected, the Predictably rotates devices between 3 and 5 times clockwise and counterclockwise as per the labeled number of rotation is manually controlled by the user's finger, thumb and hand. Also, identical to predicates, the Predict does not use electrical power or software.
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