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

    PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE

    K Number: K853987 · Decision Dec 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    28
    Review Days
    75

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    Basic Information

    Device Name
    PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE
    K Number
    K853987
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Pall Biomedical Products Co.
    Date Received
    September 27, 1985
    Decision Date
    December 11, 1985
    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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