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510(k) Data Aggregation

    K Number
    K200120
    Device Name
    LiteSaber Wire Torque Assist Device
    Manufacturer
    Vesatek, LLC
    Date Cleared
    2020-05-07

    (107 days)

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

    Vesatek, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LiteSaber WTAD is used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. The LiteSaber WTAD is not intended for use in the neurovasculature.
    Device Description
    The LiteSaber Wire Torque Assist Device (WTAD) is an electrically driven device that delivers a controlled, predictable number of rotations to guidewires. The device consists of an ergonomically designed white case, onto which is attached a guidewire holder with a pin vise clamp. Once the pin vise is screwed open, the lumen is opened to permit the insertion of guidewires ranging in size from 0.009" – 0.018" in diameter into the holder. Screwing the pin vise clamp closed causes the inserted device to be firmly clamped into place. The inside of the case contains a pack of three AAA batteries, a miniature brushed DC motor and a software driven electronic control unit (ECU). The outside of the case has a red button to turn the power on, a green light that illuminates when the unit is turned on, and a black adjustment knob at the bottom of the case to control the number of rotations. The number of rotations can be adjusted from 0 - 8 by rotating the knob in the direction shown by the indicator (increase or decrease rotations). If the user requires that the rotations be halted mid-procedure, then either the power may be turned off using the red button, or the white clamp can be held. Both actions will stop the rotations from occurring. The device is provided sterile and is intended for single use.
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    K Number
    K170684
    Device Name
    Firebow Wire Torque Assist Device
    Manufacturer
    Vesatek, LLC
    Date Cleared
    2017-06-29

    (114 days)

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

    Vesatek, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Firebow Wire Torque Assist Device is used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. The Firebow Wire Torque Assist Device is not intended for use in the neurovasculature.
    Device Description
    The Firebow Wire Torque Assist Device is an electrically driven device that delivers a controlled, predictable number of rotations to guidewires. The device consists of an ergonomically designed black case, onto which is attached a green guidewire holder with a white spring tension, push button clamp. Once the push button clamp is depressed, the lumen is opened to permit the insertion of guidewires ranging in size from 0.014" - 0.038" in diameter into the holder. Releasing the push button on the clamp causes the inserted device to be firmly clamped into place. The inside of the case contains two AAA batteries, a miniature stepper motor and a software driven electronic control unit (ECU). The outside of the case has a white button to turn the power on, a green light that illuminates when the unit is turned on, and a white adjustment knob at the bottom of the case to control the number of rotations. The number of rotations can be adjusted from 0 - 8 by rotating the knob. If the user requires that the rotations be halted midprocedure, then either the power may be turned off using the white button, or the green clamp can be held. Both actions will stop the rotations from occurring. In order to ensure that the batteries are at full capacity and that the power to the device is not accidentally turned on during shipping, an activation strip is positioned through the case and in between one of the batteries and the battery terminal to prevent completion of the electrical circuit. The device is provided sterile and is intended for single use.
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