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510(k) Data Aggregation

    K Number
    K083454
    Device Name
    NUOVOCATH
    Manufacturer
    U.S. SAFETY SYRINGES CO., INC.
    Date Cleared
    2008-12-04

    (13 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 :

    NUOVOCATH

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

    The NUOVOcath IV Catheter in size 14G to 26 G is used for venous access for the infusion of I.V. fluids, medicines into the circulating system.

    Device Description

    NUOVOCATH IV CATHETER

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "NUOVOCath IV Catheter." It is not a study report and therefore does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

    The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which means it has been cleared for market based on its similarity to existing devices, not necessarily based on new performance studies described in detail within this document.

    Therefore, I cannot extract the requested information from this text. The document's purpose is regulatory clearance, not a scientific publication detailing a performance study.

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