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510(k) Data Aggregation

    K Number
    K233783
    Device Name
    exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
    Manufacturer
    PECA Labs, Inc.
    Date Cleared
    2024-01-17

    (51 days)

    Product Code
    DSY, DYF
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PECA Labs, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
    Device Description
    The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
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