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

    QUART ARTERIAL FILTER, MODEL HBF 140

    K Number: K001787 · Decision Jun 30, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    QUART ARTERIAL FILTER, MODEL HBF 140
    K Number
    K001787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jostra Medizintechnik AG
    Date Received
    June 13, 2000
    Decision Date
    June 30, 2000
    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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