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510(k) Data Aggregation

    K Number
    K091213
    Device Name
    FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
    Manufacturer
    FOOTPRINT MEDICAL
    Date Cleared
    2009-09-25

    (151 days)

    Product Code
    FOS
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN

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

    THIS PRODUCT IS INTENDED FOR USE IN NEONATAL AND PEDIATRIC PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE OR ADMINISTER FLUIDS INTRAVENOUSLY.

    Device Description

    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, DUAL LUMEN.

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter from the FDA for a Silicone Umbilical Catheter, Dual Lumen. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

    The letter only states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act.

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

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