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

    BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR

    K Number: K862920 · Decision Sep 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    167
    Applicant Total
    566
    Review Days
    59

    Basic Information

    Device Name
    BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
    K Number
    K862920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    C.R. BARD, INC.
    Date Received
    August 1, 1986
    Decision Date
    September 29, 1986
    Product Code
    DTN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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