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510(k) Data Aggregation

    K Number
    K022212
    Device Name
    PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
    Manufacturer
    MENTOR MEDICAL LIMITED
    Date Cleared
    2003-03-21

    (256 days)

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

    MENTOR MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management.
    Device Description
    The new kit is designed to permit percutaneous creation of a tracheostomy stoma for subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. The kit contains all of the standard components to which the users are accustomed from use of the Rusch predicate device: scalpel, gauze swabs, needle and cannula, syringe, guidewire, guiding catheter, short pre-dilator and set of serial dilators which are also used for introduction of the tracheostomy tube.
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