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    K Number
    K090932
    Device Name
    NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000
    Manufacturer
    NEXGEN MEDICAL SYSTEMS, INC.
    Date Cleared
    2009-09-24

    (175 days)

    Product Code
    QEW,DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000

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

    The NexGen Peripheral Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arterial blood vessels and peripheral bypass grafts and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text primarily consists of an FDA 510(k) clearance letter for the NexGen Peripheral Mechanical Retrieval Device. It discusses the device's regulatory classification, product codes, and general compliance requirements.

    However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about clinical performance, test sets, expert involvement, or training data.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from the provided text.

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