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510(k) Data Aggregation

    K Number
    K230609
    Device Name
    NG Delivery Catheter
    Manufacturer
    Balt USA, LLC
    Date Cleared
    2023-09-13

    (191 days)

    Product Code
    QJP,DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K163259,K172014
    Why did this record match?
    Reference Devices :

    K163259

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

    The NG Delivery Catheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as distal access catheters, in the neurovasculature.

    Device Description

    The NG Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the NG Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the NG Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The NG Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.

    AI/ML Overview

    This document is a 510(k) Pre-market Notification for a medical device (NG Delivery Catheter) and, as such, does not contain information about studies related to AI/ML device performance or acceptance criteria in the context of diagnostic accuracy. The data provided focuses on the physical and biological performance of the catheter itself, demonstrating substantial equivalence to predicate devices, rather than an AI component.

    Therefore, I cannot provide the requested information regarding AI device acceptance criteria and study data. The document confirms that:

    • No clinical testing was conducted for the NG Delivery Catheter.
    • No animal testing was conducted for the NG Delivery Catheter.
    • The performance data provided is for bench testing of the physical device.

    The tables in the document describe biocompatibility testing and performance bench testing for the NG Delivery Catheter, along with their respective results and conclusions (all samples passed acceptance criteria or were acceptable/comparable). These tests are relevant to the safety and functionality of the physical catheter, not an AI/ML component.

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