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510(k) Data Aggregation

    K Number
    K030999
    Device Name
    EPTFE VASCULAR PROSTHESIS; SEALPTFE
    Manufacturer
    VASCUTEK LTD.
    Date Cleared
    2003-04-09

    (9 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K130215
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CREATION OF SUBCUTANEOUS ARTERIOVENOUS CONDUITS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.

    Device Description

    ePTFE vascular prosthesis (unsealed and gelatin sealed)

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device, specifically an ePTFE vascular prosthesis. It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

    The letter simply states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has similar indications for use, technological characteristics, and can be marketed subject to general controls.

    Therefore, I cannot extract the requested information from the provided text. The document is about regulatory clearance, not a performance study.

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