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

    CARDIOTOMY FILTER

    K Number: K830634 · Decision Jun 30, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    30
    Review Days
    121

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    Basic Information

    Device Name
    CARDIOTOMY FILTER
    K Number
    K830634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4270
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Texas Medical Products, Inc.
    Date Received
    March 1, 1983
    Decision Date
    June 30, 1983
    Product Code
    JOD
    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
    JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

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