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510(k) Data Aggregation

    K Number
    K043552
    Device Name
    VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
    Manufacturer
    VASCUTEK LTD.
    Date Cleared
    2005-01-05

    (9 days)

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

    VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES

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

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

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a letter from the FDA regarding a 510(k) premarket notification and an "Indications for Use" statement. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot provide the requested details based solely on the input provided. The content focuses on regulatory approval and the intended use of the device, not detailed performance data from a clinical or technical study.

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