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510(k) Data Aggregation

    K Number
    K040829
    Device Name
    GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR
    Manufacturer
    VASCUTEK LTD.
    Date Cleared
    2004-05-20

    (50 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR

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

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

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a vascular graft prosthesis. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as described in your request.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

    This indicates that the clearance was based on a demonstration of substantial equivalence to an already marketed predicate device, rather than a de novo clinical study with specific performance acceptance criteria. Therefore, I cannot extract the requested information from this document.

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