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510(k) Data Aggregation

    K Number
    K023872
    Device Name
    VITALCARE URETHRAL CATHETER RED RUBBER
    Manufacturer
    VITALCARE, INC.
    Date Cleared
    2003-04-10

    (141 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VitalCare's Urethral Catheter Red Rubber is intended to be inserted through the urethra to the bladder and utilized for passage of fluid from the urinary tract.

    Device Description

    Urethral Catheter Red Rubber

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device, the "VitalCare Urethral Catheter Red Rubber." However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).

    The document is primarily a notification of substantial equivalence to a predicate device (Kendall Dover Red Rubber Robinson Catheter) and outlines the intended use and technological features comparison. The FDA's response confirms the substantial equivalence determination, classifying the device and permitting its market entry based on this comparison.

    Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study particulars, as these details are not present in the provided text.

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