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510(k) Data Aggregation

    K Number
    K960766
    Device Name
    MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Date Cleared
    1997-03-19

    (387 days)

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

    MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

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

    The ePTFEMEADS Vascular access. Mid-Flex grafts are specifically indicated for vascular --access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.

    Device Description

    The ePTFEMENOx Vasular Graft is comprised of an expanded polyenced the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

    AI/ML Overview

    This document is a Premarket Notification (510(k)) for a medical device submitted in 1996. It does not describe a study involving an AI/Machine Learning device or software, nor does it contain acceptance criteria or performance data in the context of such studies.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on establishing substantial equivalence for a physical medical device (ePTFE Vascular Graft) to predicate devices already on the market, based on material, manufacturing, and general performance specifications.

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