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510(k) Data Aggregation

    K Number
    K181870
    Device Name
    Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
    Manufacturer
    Wuhan W.E.O Science & Technology Development Co., Ltd.
    Date Cleared
    2019-02-26

    (229 days)

    Product Code
    FPA,FPB
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K161898,K974661,K061115
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system for short term infusions only.

    The Precision Infusion Filter for Single Use is intended to be used with administration sets for removal of particulate matter during the administration of fluids or medications.

    The Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration.

    Device Description

    The purpose of this submission was to introduce new products into interstate commerce. This is a bundled submission which includes Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use and Extended Infusion Sets for Single Use.

    Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system under the action of gravity. The proposed devices are comprised of protective cap, closure-piercing device, air vent, drip chamber, precision filter, flexible tubing, injection site, flow regulator, clamp, conical fitting, burette and needle tube. The devices are provided sterile and single use.

    Precision Infusion Filter for Single Use is intended to be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications. The proposed devices are comprised of protective Cap and precision filter. The devices are provided sterile and single use.

    Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration. The proposed devices are comprised of protective Cap, flexible tubing, conical fitting and precision filter. The devices are provided sterile and single use.

    AI/ML Overview

    This document describes various infusion sets and filters, but it does not describe a study involving an AI device. The document is for a 510(k) premarket notification for medical devices (infusion sets and filters), focusing on demonstrating substantial equivalence to predicate devices, not on AI performance. Therefore, I cannot provide an answer based on the provided text.

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