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510(k) Data Aggregation

    K Number
    K080339
    Device Name
    MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
    Manufacturer
    MEDSOURCE INTERNATIONAL, LLC.
    Date Cleared
    2008-10-27

    (262 days)

    Product Code
    BTR
    Regulation Number
    868.5730
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    Matched: '868.5790'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management. Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.
    Device Description
    MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet: • Constructed of Polyvinylchloride • Single lumen tube with or without a cuff; • Tapered tip with Murphy Eye; • Clear medical-grade tubing(polyvinyl) with graduations; • Connector with check valve; • Pre-loaded with Stylet having a low friction coating; • Various sizes • Sterile Single-Use Device
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