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510(k) Data Aggregation

    K Number
    K050038
    Device Name
    RELIANT STENT GRAFT BALLOON CATHETER
    Manufacturer
    MEDTRONIC ENDOVASCULAR INNOVATIONS
    Date Cleared
    2005-04-13

    (96 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K032869,K003495,K002286
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC ENDOVASCULAR INNOVATIONS

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

    The Reliant Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for the Reliant Stent Graft Balloon Catheter. It outlines the device's intended use, classification, and predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    This document primarily serves to demonstrate substantial equivalence to previously cleared devices based on intended use, overall catheter configuration, and performance characteristics (which are assumed to be similar to the predicates but not detailed in this summary).

    Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about related studies based only on the provided text. This information would typically be found in more comprehensive testing summaries or clinical trial reports submitted as part of the 510(k) application, but it is not present in this specific summary document.

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