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

    MODIFICATION TO ACS CORONARY GUIDING

    K Number: K841992 · Decision Jun 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    103
    Review Days
    47

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    Basic Information

    Device Name
    MODIFICATION TO ACS CORONARY GUIDING
    K Number
    K841992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Cardiovascular Systems, Inc.
    Date Received
    April 25, 1984
    Decision Date
    June 11, 1984
    Product Code
    DAO
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control

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