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    K Number
    K072997
    Device Name
    NEOMED URINARY CATHETER
    Manufacturer
    NEOMED, INC.
    Date Cleared
    2007-12-19

    (56 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K944782
    Why did this record match?
    Device Name :

    NEOMED URINARY CATHETER

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

    The NeoMed Urinary Catheter is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days.

    Device Description

    The NeoMed Urinary Catheter is a silicone single lumen catheter that is used to drain urine. The device consists of the following main components: a single lumen urinary catheter, a hub, and a luer lock connector. It is available with either an orange radiopaque stripe or a natural white stripe (supplied from the barium sulfate loaded in the catheter).

    AI/ML Overview

    The provided text describes the NeoMed Urinary Catheter and its clearance for market based on substantial equivalence to a predicate device, the CATCO Urological Catheter (K944782). The key information for acceptance criteria and the supporting study is:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document summarizes the acceptance criteria and performance based on equivalence to the predicate device.

    Acceptance CriteriaReported Device Performance Statement
    Method of OperationSame method of operation as predicate: drainage of urine through a single lumen catheter.
    Functional EquivalenceBench testing demonstrated functional equivalence to predicate and other urinary catheters.
    Safety and EffectivenessMinor differences do not affect safety or effectiveness.
    BiocompatibilityMaterials have a long history of use in catheter and urethral catheter manufacture and are biocompatible.
    Intended Use PerformancePerforms its intended use of urine drainage.
    Duration of ContactIntended for temporary use (
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