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510(k) Data Aggregation

    K Number
    K240775
    Device Name
    PeriBeam® Pericardial Membrane
    Manufacturer
    TamaBio
    Date Cleared
    2025-04-18

    (393 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    TamaBio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PeriBeam® Pericardial Membrane is indicated for the reconstruction or repair of the pericardium.
    Device Description
    PeriBeam® is an ion-irradiated, expanded polytetrafluoroethylene (ePTFE) membrane used for reconstruction or repair of the pericardium. This device is intended for use as a temporary or permanent prosthesis for repair of pericardium
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