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510(k) Data Aggregation

    K Number
    K090576
    Device Name
    FOOTPRINT URINARY DRAINAGE CATHETER
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-08-12

    (162 days)

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

    FOOTPRINT URINARY DRAINAGE CATHETER

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

    The Footprint Urinary Drainage Catheter is a flexible tube intended for drainage of urine from small pediatric or Neonatal patients. This is a prescription device intended for use for less than 30 days. It is not implanted and is not a life supporting device.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA regarding a urinary drainage catheter. It does not contain information about the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an approval letter for the device, stating it is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the provided text.

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