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510(k) Data Aggregation

    K Number
    K090122
    Device Name
    NUOVOGUARD
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2009-02-05

    (15 days)

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

    NUOVOGUARD

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

    NUOVOguard IV Catheter in sizes 14G to 26G is used to provide access into the peripheral vascular system for the administration of fluids and drugs and for withdrawal of blood. The NUOVOguard provides a passive safety tip clip to protect from the accidental needle stick injury after cannulations

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot extract any information about acceptance criteria, study details, or device performance as requested. The document is an FDA 510(k) clearance letter for an Intravascular Catheter, which primarily focuses on the regulatory aspects of the device's market approval rather than detailed performance study results.

    The document states that the device, "US SAFETY SYRINGES CO. NUOVOguard IV Catheter," is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" which describe the purpose of the device (providing access into the peripheral vascular system for fluid/drug administration and blood withdrawal, and having a passive safety tip to prevent needle stick injury). However, it does not contain the specific performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications that you are requesting.

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