BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff

    K Number: K193077 · Decision Jun 1, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    130
    Review Days
    209

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    Basic Information

    Device Name
    Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
    K Number
    K193077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien
    Date Received
    November 5, 2019
    Decision Date
    June 1, 2020
    Product Code
    JOH
    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
    JOH Tube Tracheostomy And Tube Cuff

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