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510(k) Data Aggregation

    K Number
    K041917
    Device Name
    PLASIATEK ACTUATOR
    Manufacturer
    Date Cleared
    2005-01-07

    (175 days)

    Product Code
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLASIATEK, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PlasiaTEK Actuator is a non-invasive accessory to support verification of placement of an endotracheal tube within the trachea using Doppler ultrasound imaging.
    Device Description
    The PlasiaTEK™ Actuator Device is a small, non-invasive, battery operated vibrating accessory with an on/off switch that is attached to the ventilation circuit connector on the proximal end of an endotracheal tube. The PlasiaTEK Actuator is used in combination with a previously cleared-to-market endotracheal tube and standard Doppler ultrasound system to locate the endotracheal tube within the trachea. When turned on, the Actuator slightly vibrates the tube. An imaging Doppler ultrasound system can detect the endotracheal tube position because of the gentle small motion caused by the PlasiaTEK Actuator.
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