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

    COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)

    K Number: K965214 · Decision Mar 28, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    10
    Review Days
    88

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    Basic Information

    Device Name
    COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
    K Number
    K965214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coeur Laboratories, Inc.
    Date Received
    December 30, 1996
    Decision Date
    March 28, 1997
    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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