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

    EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40

    K Number: K882137 · Decision Aug 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    15
    Review Days
    84

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    Basic Information

    Device Name
    EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40
    K Number
    K882137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Blood Systems, Inc.
    Date Received
    May 20, 1988
    Decision Date
    August 12, 1988
    Product Code
    DTM
    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
    DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

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