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

    SHILEY PREBYPASS FILTER

    K Number: K840450 · Decision Apr 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    174
    Review Days
    76

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    Basic Information

    Device Name
    SHILEY PREBYPASS FILTER
    K Number
    K840450
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Shiley, Inc.
    Date Received
    February 1, 1984
    Decision Date
    April 17, 1984
    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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