BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HYCULT DIAMOND CORONARY BYPASS KNIFE

    K Number: K900379 · Decision Mar 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    313
    Registration Numbers
    313
    Same Product Code
    70
    Applicant Total
    23
    Review Days
    52

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    Basic Information

    Device Name
    HYCULT DIAMOND CORONARY BYPASS KNIFE
    K Number
    K900379
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.4500
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    St. Jude Medical, Inc.
    Date Received
    January 26, 1990
    Decision Date
    March 19, 1990
    Product Code
    DWS
    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
    DWS Instruments, Surgical, Cardiovascular

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