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

    STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

    K Number: K103469 · Decision Jan 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    13
    Applicant Total
    20
    Review Days
    55

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    Basic Information

    Device Name
    STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
    K Number
    K103469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4205
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Group Deutschland GmbH
    Date Received
    November 24, 2010
    Decision Date
    January 18, 2011
    Product Code
    KRL
    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
    KRL Detector, Bubble, Cardiopulmonary Bypass

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