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510(k) Data Aggregation

    K Number
    K063442
    Device Name
    ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    2007-03-26

    (132 days)

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

    ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR

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

    All Silicone Foley Catheter intended for urological use only. Foley Catheter 2-way: for routine drainage of the urinary bladder. Foley Catheter 3-way: for drainage of the urinary bladder and bladder irrigation. Foley Catheter with Temperature Sensor: for drainage of the urinary bladder and simultaneous monitoring of temperature. Prescription use only.

    Device Description

    Urinary Foley catheter

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for a Foley Catheter. It discusses the regulatory approval, but it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

    Therefore, I cannot fulfill your request based on the provided text. The document is about a traditional medical device (a catheter), not a device that relies on AI/ML.

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