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

    SYMMETRY AORTIC CLIP SYSTEM

    K Number: K003446 · Decision May 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    196

    Basic Information

    Device Name
    SYMMETRY AORTIC CLIP SYSTEM
    K Number
    K003446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ST. JUDE MEDICAL CARDIOVASCULAR GROUP, INC.
    Date Received
    November 6, 2000
    Decision Date
    May 21, 2001
    Product Code
    NCA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NCA Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

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