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510(k) Data Aggregation

    K Number
    K992268
    Device Name
    NAC PRN NEEDLELESS ACCESS CONNECTOR
    Manufacturer
    THE KIPP GROUP
    Date Cleared
    1999-09-15

    (71 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 :

    NAC PRN NEEDLELESS ACCESS CONNECTOR

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

    The NAC PRN Needleless Access Connector is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called the "NAC PRN Needleless Access Connector." While it confirms the device's substantial equivalence to a predicate device and its regulatory classification, it does not contain any information about acceptance criteria for device performance or any studies that demonstrate the device meets such criteria.

    The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from this text.

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