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

    CHARTIS CATHETER

    K Number: K083883 · Decision Jun 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    33
    Applicant Total
    4
    Review Days
    178

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    Basic Information

    Device Name
    CHARTIS CATHETER
    K Number
    K083883
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5740
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pulmonx, Inc.
    Date Received
    December 29, 2008
    Decision Date
    June 25, 2009
    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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    Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)

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    Other Clearances by Pulmonx, Inc.

    K Number Device Name
    K111764 CHARTIS CONSOLE
    K111522 CHARTIS CATHETER MODEL CHR-CA-12.0
    K083199 CHARTIS CONSOLE