BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    PeriBeam® Pericardial Membrane

    K Number: K240775 · Decision Apr 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    89
    Applicant Total
    1
    Review Days
    393

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    Basic Information

    Device Name
    PeriBeam® Pericardial Membrane
    K Number
    K240775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tamabio
    Date Received
    March 21, 2024
    Decision Date
    April 18, 2025
    Product Code
    DXZ
    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
    DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

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