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

    SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT

    K Number: K952879 · Decision Apr 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    505
    Review Days
    304

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    Basic Information

    Device Name
    SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
    K Number
    K952879
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Healthcare Corp
    Date Received
    June 23, 1995
    Decision Date
    April 22, 1996
    Product Code
    KFM
    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
    KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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