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

    Chartis Precision Catheter

    K Number: K222340 · Decision Dec 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    33
    Applicant Total
    4
    Review Days
    120

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    Basic Information

    Device Name
    Chartis Precision Catheter
    K Number
    K222340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5740
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulmonx Corporation
    Date Received
    August 3, 2022
    Decision Date
    December 1, 2022
    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 Corporation

    K Number Device Name
    K253096 Chartis Precision Catheter
    K212494 Lung Image Analysis
    K180011 Pulmonx Chartis Tablet Console