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

    STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM

    K Number: K101046 · Decision Dec 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    20
    Review Days
    239

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    Basic Information

    Device Name
    STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
    K Number
    K101046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Deutschland GmbH
    Date Received
    April 14, 2010
    Decision Date
    December 9, 2010
    Product Code
    DTX
    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
    DTX Gas Control Unit, Cardiopulmonary Bypass

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