LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060741
    Device Name
    SWIRLGRAFT VASCULAR ACCESS GRAFT
    Manufacturer
    VERYAN MEDICAL LIMITED
    Date Cleared
    2006-04-05

    (16 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K094044
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SwirlGraft™ Vascular Access Graft is intended for use as a subcutaneous arterio-venous conduit for vascular access.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Veryan SwirlGraft™ Vascular Access Graft. It confirms the device's substantial equivalence to a legally marketed predicate device.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.

    Therefore, I cannot fulfill your request using only the provided text. To answer your questions, I would need a detailed study report or clinical trial summary for the Veryan SwirlGraft™ Vascular Access Graft.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1