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

    INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70

    K Number: K861226 · Decision Jun 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    21
    Review Days
    62

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    Basic Information

    Device Name
    INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70
    K Number
    K861226
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical, Inc.
    Date Received
    April 1, 1986
    Decision Date
    June 2, 1986
    Product Code
    KRJ
    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
    KRJ Filter, Prebypass, Cardiopulmonary Bypass

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