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

    FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS

    K Number: K984586 · Decision Jun 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    168
    Applicant Total
    3
    Review Days
    187

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    Basic Information

    Device Name
    FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
    K Number
    K984586
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fresenius Hemotechnology, Inc.
    Date Received
    December 24, 1998
    Decision Date
    June 29, 1999
    Product Code
    DTN
    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
    DTN Reservoir, Blood, Cardiopulmonary Bypass

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    Other Clearances by Fresenius Hemotechnology, Inc.

    K Number Device Name
    K012178 FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
    K984233 C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE