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510(k) Data Aggregation

    K Number
    K252459

    Validate with FDA (Live)

    Date Cleared
    2026-02-10

    (189 days)

    Product Code
    Regulation Number
    876.5860
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K242053, K212216

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The multiFlux 130 and 160 filters are intended for single use only for extracorporeal blood purification during continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVHD), and continuous veno-venous hemodiafiltration (CVVHDF) using pre-, post- or mixed-dilution modes for patients suffering from acute kidney injury.

    Device Description

    The multiFlux 130 and 160 hemofilters are high-flux, single-use, steam-sterilized filters. The hemofilters are provided blood pathway sterile and non-pyrogenic. The hemofilters allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.

    The multiFlux 130 and 160 hemofilters are high-flux, sterile devices designed for single-use acute hemodialysis. The hemofilters are 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 hemofilters. The hemofilters contain semi-permeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Hemofilters utilize a counter-current flow in which dialysate and blood flow in opposite directions in the hemofilter. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.

    The multiFlux 130 and 160 hemofilters' components are composed of the following materials:
    Housing: Polypropylene
    Potting Resin: Polyurethane
    Fiber Bundle: Polysulfone-polyvinylpyrrolidone blend, alpha-tocopherol (vitamin E)
    Sealing Ring: Silicone
    Flange: Polypropylene
    Blood Port Cap(s): Polypropylene
    Dialysate Port Cap(s): Styrol-Ethylen-Butylen-Styrol, Polypropylene

    AI/ML Overview

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