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510(k) Data Aggregation

    K Number
    K021939
    Device Name
    VITALCARE FOLEY CATHETER
    Manufacturer
    VITALCARE, INC.
    Date Cleared
    2003-04-22

    (314 days)

    Product Code
    EZL
    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 Foley Catheters are intended to be inserted through the urethra to the bladder and utilized for passage of fluid from /to the urinary tract.

    Device Description

    Urological Foley Catheter

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary and approval letter for a medical device (VitalCare Foley Catheter), which primarily focuses on its intended use, comparison to a predicate device, and regulatory classification. It does not include details on clinical trials, performance metrics, or study design.

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