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510(k) Data Aggregation

    K Number
    K060142
    Device Name
    VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
    Manufacturer
    VASCUTEK LTD.
    Date Cleared
    2006-02-07

    (19 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K090987,K162794
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    REPAIR OR REPLACEMENT OF DAMAGED AND DISEASED VESSELS OF THE THORACIC AORTA IN ANEURYSM, DISSECTION OR CASES OF COARCTATION.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria of a device, performance studies, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for "Gelweave Siena Collared Ante-Flo and Plexus Vascular Grafts with Radiopaque Markers," indicating that the device has been determined substantially equivalent to a legally marketed predicate device. It outlines regulatory requirements and the device's indications for use but does not delve into the specifics of a performance study or acceptance criteria.

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