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510(k) Data Aggregation

    K Number
    K080665
    Device Name
    NOVOLET
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2008-05-13

    (64 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NOVOLET

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

    Novolet Scalp Vein Blood Collection Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device (US SAFETY SYRINGES CO. Novolet Blood Collection Set). It confirms the device's substantial equivalence to a predicate device and outlines regulatory responsibilities.

    This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

    The document is purely a regulatory clearance for a physical medical device (a blood collection set) and does not describe any software or AI components. Therefore, I cannot generate the requested information based on this input.

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