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510(k) Data Aggregation

    K Number
    K092172
    Device Name
    EXEL I.V. EXTENSION SET
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2010-01-04

    (167 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The I.V. Extension Set is an accessory device used for infusion of medication intravenously into the patient.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an "I.V. Extension Set." This document does not contain any information regarding acceptance criteria, device performance details, or any study results.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details regulatory requirements but does not include any technical or performance specifications or clinical study summaries.

    Therefore, I cannot provide the requested information based on the given text.

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