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510(k) Data Aggregation

    K Number
    K200761
    Device Name
    Tenax Laser Resistant Endotracheal Tube
    Manufacturer
    Bryan Medical, Inc.
    Date Cleared
    2020-11-25

    (246 days)

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

    Bryan Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns) or KTP (532 nm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway.
    Device Description
    The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is indicated for use in surgical procedures where intubation is required in the presence of KTP or CO2 lasers. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.
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