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510(k) Data Aggregation

    K Number
    K192324
    Device Name
    Sheridan Spiral-Flex Endotracheal Tubes
    Date Cleared
    2019-12-06

    (101 days)

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

    TeleflexMedical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sheridan cuffed, uncuffed and reinforced tracheal tubes are designed for oral or nasal intubation and are indicated for airway management.
    Device Description
    The Sheridan Spiral-Flex Endotracheal Tubes are spiral tracheal tubes that are inserted into the trachea via the mouth or the nose in order to establish a patent airway to allow ventilation. The subject device are sterile, single use devices. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. Each tracheal tube is supplied with an appropriately sized 15mm connector.
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