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510(k) Data Aggregation

    K Number
    K092382
    Manufacturer
    Date Cleared
    2010-04-26

    (264 days)

    Product Code
    Regulation Number
    880.5440
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEXUS PRESSURE RATED EXTENSION SETS

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

    The Nexus Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities that utilize infusion systems to administer IV fluids, medications, blood and blood products to the patient's vascular system and may be safely used with power injectors at pressures up to 325 psi. The needle-free design allows the user to add medication into the primary line and may also aid in the prevention of needle stick injuries.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device (Nexus Pressure Rated Extension Sets), confirming its substantial equivalence to a predicate device for marketing. It outlines regulatory requirements and contact information but does not contain detailed study results, performance data, or an explicit list of acceptance criteria for the device itself.

    Therefore, I cannot provide the requested table and study details.

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