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510(k) Data Aggregation

    K Number
    K031794
    Device Name
    ENDOFLEX TRACHEAL TUBE
    Manufacturer
    MERLYN ASSOCIATES INC.
    Date Cleared
    2004-03-12

    (276 days)

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

    MERLYN ASSOCIATES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoFlex Tracheal Tube is intended for airway management by oral/nasal intubation.
    Device Description
    The EndoFlex Tracheal Tube is sterile, single use device for airway management during anesthesia and mechanical ventilation. The tube is made in fifteen sizes; 3.0mm through 10.0mm in 0.5 mm increments. The EndoFlex Tracheal tube is identical to the predicate devices in terms of material composition, biocompatibility, and sterilization. The EndoFlex Tracheal tube has a beveled tip, high volume/low pressure cuff, inflation system, and 15mm connector equivalent to the predicate devices. The EndoFlex Tracheal tube differs from the predicate device in the following ways: The EndoFlex Tracheal tube has an articulating tip that can be flexed to facilitate intubation. The flexing tip eliminates the need for intubation stylets.
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