BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PORTEX PERCUTANEOUS TRACHEOSTOMY KIT

    K Number: K060945 · Decision Jun 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    1
    Review Days
    74

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    Basic Information

    Device Name
    PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
    K Number
    K060945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Smiths Medical International
    Date Received
    April 6, 2006
    Decision Date
    June 19, 2006
    Product Code
    BTO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTO Tube, Tracheostomy (W/Wo Connector)

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