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

    ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING

    K Number: K864262 · Decision Jan 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    206
    Review Days
    65

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    Basic Information

    Device Name
    ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
    K Number
    K864262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    October 29, 1986
    Decision Date
    January 2, 1987
    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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