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510(k) Data Aggregation

    K Number
    K210331
    Device Name
    CardiaMend Pericardial and Epicardial Reconstruction Matrix
    Manufacturer
    Helios Cardio Inc.
    Date Cleared
    2021-12-21

    (319 days)

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

    Helios Cardio Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.
    Device Description
    CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is a porous acellular matrix derived from fetal bovine dermis designed to provide soft tissue reinforcement, repair, and reconstruction. The single-layer (1 ply) device is not chemically crosslinked and consists of a naturally woven network of collagen fibers. The single use device is supplied terminally sterilized via ethylene oxide and is available in a variety of sizes to be trimmed by the physician to meet individual patient needs.
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