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510(k) Data Aggregation

    K Number
    K133351
    Device Name
    NEXUS NIS-6P LUER ACTIVATED DEVICE
    Manufacturer
    NEXUS MEDICAL LLC
    Date Cleared
    2014-05-22

    (203 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 :

    NEXUS NIS-6P LUER ACTIVATED DEVICE

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

    The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus NIS®-6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi. The Nexus NIS®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

    Device Description

    The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure device. It has a pre-slit septum which does not require the use of a stainless steel needle.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Nexus NIS-6P". It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. This document primarily focuses on the FDA's regulatory review and determination of substantial equivalence for the device.

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