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510(k) Data Aggregation

    K Number
    K061958
    Device Name
    MEDTRONIC EXPORT XT CATHETER
    Manufacturer
    MEDTRONIC VASCULAR
    Date Cleared
    2006-09-05

    (56 days)

    Product Code
    QEZ,DXE,KRA
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K040869
    Why did this record match?
    Device Name :

    MEDTRONIC EXPORT XT CATHETER

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

    The Medtronic Export® XT Catheter is indicated for:

    • Removal/aspiration of embolic material (thrombus/debris) from vessels . of the arterial system, and
    • To subselectively infuse/deliver diagnostics or therapeutics agents with . or without vessel occlusion.
    Device Description

    The Medtronic Export XT Catheter is a dual lumen catheter used for the aspiration of thrombus and/or debris from a vascular site. The Medtronic Export XT Catheter may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site.

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, specific studies, sample sizes, expert involvement, adjudication methods, or ground truth details. The document is an FDA 510(k) clearance letter for the Medtronic Export XT Catheter, focusing on its substantial equivalence to a predicate device and outlining regulatory information. It does not contain details about specific performance studies or statistical data.

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