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510(k) Data Aggregation

    K Number
    K252569
    Device Name
    Carrier XL Delivery Catheter
    Manufacturer
    Balt USA, LLC
    Date Cleared
    2025-10-22

    (69 days)

    Product Code
    QJP
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K230609
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Carrier XL 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 Carrier XL 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 Carrier XL Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier XL 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 Carrier XL Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.

    AI/ML Overview

    N/A

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