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

    MODIFIED GELMAN ARTERIAL FILTER

    K Number: K892387 · Decision Jun 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    32
    Review Days
    69

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    Basic Information

    Device Name
    MODIFIED GELMAN ARTERIAL FILTER
    K Number
    K892387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Gelman Sciences, Inc.
    Date Received
    April 14, 1989
    Decision Date
    June 22, 1989
    Product Code
    DTM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    TX
    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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