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

    CHARTIS CATHETER MODEL CHR-CA-12.0

    K Number: K111522 · Decision Sep 29, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    33
    Applicant Total
    4
    Review Days
    119

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    Basic Information

    Device Name
    CHARTIS CATHETER MODEL CHR-CA-12.0
    K Number
    K111522
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5740
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulmonx, Inc.
    Date Received
    June 2, 2011
    Decision Date
    September 29, 2011
    Product Code
    CBI
    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
    CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

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    Other Clearances by Pulmonx, Inc.

    K Number Device Name
    K111764 CHARTIS CONSOLE
    K083883 CHARTIS CATHETER
    K083199 CHARTIS CONSOLE