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510(k) Data Aggregation

    K Number
    K192928
    Device Name
    Optiflux Enexa F500 Dialyzer
    Date Cleared
    2020-07-09

    (266 days)

    Product Code
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fresenius Medical Care Reanal Therapies Group LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Optiflux® Enexa™ dialyzers are intended for patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.
    Device Description
    The Optiflux Enexa F500 dialyzer is a high-flux, single-use, e-beam sterilized hemodialyzer that contains the additive Endexo SMM1 blended into the fiber. The dialyzer is provided blood pathway sterile and non-pyrogenic. The membrane surface area is 1.5 m². The Optiflux Enexa F500 dialyzer is a high-flux, sterile device designed for single-use in acute and chronic hemodialysis. The dialyzer is configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that allows for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
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