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510(k) Data Aggregation

    K Number
    K091214
    Device Name
    FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
    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 SILICONE UMBILICAL CATHETER

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

    THIS CATHETER IS FOR USE IN NEWBORN PEDIATRIC OR NEONATAL PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE AND ADMINISTER I.V.FLUIDS THROUGH AN UMBILICAL VESSEL.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a "Silicone Umbilical Catheter," confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and indications for use but does not detail device performance, study methodologies, or ground truth establishment.

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