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    K Number
    K093135
    Device Name
    VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
    Manufacturer
    VENNER MEDICAL (SINGAPORE) PTE LTD
    Date Cleared
    2010-04-02

    (179 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Venner PneuxP.Y.TM EndoTracheal Tube (ETT) is an endotracheal tube intended to be used for patients undergoing tracheal tube intubation during extended periods (not more than 30 deays) and for evacuation or drainage of secretion from the subglottice space. It is also compatible with tracheal intubation during routine anesthesia.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) clearance letter from the FDA for the "Venner Pneux P. Y. EndoTracheal Tube." It primarily discusses the regulatory approval process, the device's classification, and general compliance requirements, but it does not detail any specific acceptance criteria for performance or a study demonstrating the device meets such criteria.

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