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

    CATHETER, MEDIASTINAL&PERICARDIAL

    K Number: K771986 · Decision Oct 28, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    9

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    Basic Information

    Device Name
    CATHETER, MEDIASTINAL&PERICARDIAL
    K Number
    K771986
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4370
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The Minnesota Back Brace Co.
    Date Received
    October 19, 1977
    Decision Date
    October 28, 1977
    Product Code
    FHF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FHF System, Evacuator, Fluid

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