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

    BRONCHO-CATH

    K Number: K771219 · Decision Aug 4, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    92
    Review Days
    30

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    Basic Information

    Device Name
    BRONCHO-CATH
    K Number
    K771219
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Critical Care
    Date Received
    July 5, 1977
    Decision Date
    August 4, 1977
    Product Code
    BTS
    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
    BTS Tube, Bronchial (W/Wo Connector)

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