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510(k) Data Aggregation

    K Number
    K130507
    Device Name
    FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
    Manufacturer
    FOOTPRINT MEDICAL INC.
    Date Cleared
    2013-06-03

    (96 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER

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

    This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: Medications, TPN nutritional solutions, and Intravenous infusion of fluids are needed.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information about a study proving the device meets acceptance criteria, nor any details regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or ground truth establishment.

    The document is a letter from the FDA to Footprint Medical, Incorporated, confirming that the "Footprint Medical Polyurethane PICC Catheter" (K130507) has been found substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information about marketing the device. The "Indications for Use" section specifies the intended patient population (neonatal and small pediatric) and applications (medications, TPN, IV fluids).

    Therefore, I cannot provide the requested table or details about a study and its methodology.

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