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510(k) Data Aggregation

    K Number
    K252277
    Date Cleared
    2025-10-20

    (90 days)

    Product Code
    Regulation Number
    870.3450
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spiral Laminar Flow Vascular Arteriovenous Graft is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis.

    Device Description

    SLF™ Vascular Arteriovenous Grafts are straight tubes constructed of expanded polytetrafluoroethylene (ePTFE) with the unique spiral flow inducer and nonremovable external inducer indicator ring (palpable ring) formed from ChronoFlex™* AL-80A, a Biodurable Medical Grade polyurethane. The spiral flow inducer is a helical deformation in the wall of the graft. The inducer indicator ring is on the outer surface of the proximal end of the spiral flow inducer, indicating the beginning of the spiral inducer segment and the no cannulation area of the graft.

    A Shaped Hood is provided to guide the surgeon when creating the distal anastomosis. Although not critical to the functioning of the device, the hood does provide for an effective attachment angle and alignment of the spiral flow inducer with the native vessel

    All grafts are supplied sterile and will remain so for the stated shelf life unless the packaging is opened or damaged.

    SLF™ Vascular Arteriovenous grafts are available in one size (Table 1).

    Table 1: SLF Graft Dimensions

    DeviceDiameterLength
    SLF™ Vascular Arteriovenous Grafts6 mm450 mm
    AI/ML Overview

    N/A

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