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510(k) Data Aggregation

    K Number
    K251864

    Validate with FDA (Live)

    Device Name
    Rubber Utility Catheter
    Manufacturer
    C.R. Bard, Inc.
    Date Cleared
    2026-02-23

    (251 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    2 - 120
    Reference & Predicate Devices
    K222677,K041243
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K222677

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

    The BD Rubber Utility Catheter is indicated for intermittent catheterization of the urethra to drain urine from the bladder by patients who are not capable of voluntary urination.

    Device Description

    The BD Rubber Utility Catheter is an uncoated, latex, intermittent urethral catheter that is provided sterile and intended for single use. It is intended for the drainage of urine from the bladder via intermittent urethral catheterization. The device is intended for use in adult and pediatric patients 2 years of age or older. Selection of the appropriate catheter size should be determined by the patient's healthcare provider based on clinical judgement.

    AI/ML Overview

    N/A

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