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510(k) Data Aggregation

    K Number
    K260533

    Validate with FDA (Live)

    Device Name
    ELISIO™-H
    Date Cleared
    2026-03-19

    (30 days)

    Product Code
    Regulation Number
    876.5860
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ELISIO™-H dialyzers are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

    Device Description

    The ELISIO™-H is a single-use, high-flux hemodialyzer intended for the extracorporeal treatment of patients with renal failure. The device is constructed of a plastic cylindrical housing comprised of two compartments, one for blood and one for dialysate, separated by a semi-permeable membrane. Blood is circulated through the blood compartment, while dialysate flows counter currently through the dialysate compartment. This flow pattern enables the removal of uremic toxins, excess fluid, and electrolytes via diffusion and/or convection, depending on the selected treatment modality.

    The dialyzer interfaces with the patient via an ISO 8637 compliant blood tubing set and must be used with dialysis machines equipped with an ultrafiltration controller or accurate fluid balancing system. The ELISIO™-H features the POLYNEPHRON™ membrane (Polyethersulfone), for high clearance efficiency and a polypropylene housing not made with BPA or DEHP.

    The device is available in eight sizes (surface area): 0.9, 1.1, 1.3, 1.5, 1.7, 1.9, 2.1, and 2.5 m². It is sterile (gamma radiation) and non-pyrogenic with a three-year shelf life. No integrated components or accessories are included.

    AI/ML Overview

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