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

    STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE

    K Number: K925661 · Decision May 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    13
    Applicant Total
    20
    Review Days
    189

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    Basic Information

    Device Name
    STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
    K Number
    K925661
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4205
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    November 10, 1992
    Decision Date
    May 18, 1993
    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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