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

    ATLAAS (Atraumatic Left Atrial Appendage System) (AD)

    K Number: K252917 · Decision May 22, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    8
    Applicant Total
    14
    Review Days
    252

    Basic Information

    Device Name
    ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
    K Number
    K252917
    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
    Genesee Biomedical, Inc.
    Date Received
    September 12, 2025
    Decision Date
    May 22, 2026
    Product Code
    PZX
    Advisory Committee
    General, Plastic Surgery
    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
    PZX Left Atrial Appendage Clip, Implantable

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