Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K101721
    Device Name
    WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
    Manufacturer
    REGULATORY AND MARKETING SERVICES, INC.
    Date Cleared
    2011-03-24

    (279 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGULATORY AND MARKETING SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Well lead Tracheostomy Tubes and Disposable Inner Cannula is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.
    Device Description
    The Well lead Tracheostomy Tubes and Disposable Inner Cannula includes an outer cannula, disposable inner cannula, introducer, neck strap and obturator. The disposable inner cannula acts as a removable liner for the outer tube; it can be withdrawn and changed after the airway has been cleaned, such as phlegm suction. The disposable inner cannula facilitates the airway management to make it easy to clean and prolong the use of the device. The device is used to provide an artificial airway in order to provide access to the patient's airway for airway management. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The tracheostomy tube is secured by the means of the swivel neck plate/flange. When appropriately connected the device provides a secure artificial airway for spontaneous or mechanical ventilation.
    Ask a Question

    Page 1 of 1