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510(k) Data Aggregation

    K Number
    K984528
    Device Name
    PARKER FLEX-TIP TRACHEAL TUBE
    Manufacturer
    PARKER MEDICAL ASSOC.
    Date Cleared
    1999-07-15

    (206 days)

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

    PARKER MEDICAL ASSOC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Parker cuffed tubes are designed for oral intubation and are indicated for airway management.
    Device Description
    The Parker tracheal tubes are sterile, single use devices, for use in anesthesia and emergent and respiratory care where mechanical ventilation is required. The tube will be made in four sizes: 6.5, 7.0, 7.5, and 8.0 mm ID. It is identical to the predicate device in material composition, biocompatibility, packaging, sterilization, and in all structural respects, except for the following features: - (1) Instead of a semi-rigid, side-beveled distal tip, the Parker tube has a flexible, slightly rounded, rear-beveled distal tip which tapers centrally toward the midline of the lesser curvature of the tube. - (2) Instead of a single, lateral Murphy eye opposite the bevel, the Parker tube has two, facing Murphy eyes flanking the bevel. - (3) Instead of a radiopaque stripe on the greater curvature of the tube and a cuff inflation circuit on the lesser curvature of the tube, the positions of these two features are reversed on the Parker tube.
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