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510(k) Data Aggregation

    K Number
    K022634
    Device Name
    CO-AXIAL INTRODUCER NEEDLE
    Manufacturer
    PROMEX, INC.
    Date Cleared
    2002-11-06

    (90 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K171853,K241145
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be used for percutaneous transjugular li access during diagnostic and interventional procedures.

    Device Description

    Co-Axial Introducer Needle; Co-Axial Introducer Set/Transjugular Liver Access Set

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called a "Co-Axial Introducer Needle" or "Co-Axial Introducer Set/Transjugular Liver Access Set" manufactured by Promex, Inc.

    The letter grants clearance for the device to be marketed based on its substantial equivalence to a legally marketed predicate device. This type of regulatory document does not contain information about specific acceptance criteria or detailed study results proving a device meets those criteria, particularly not in the context of an AI/ML device where performance metrics like sensitivity, specificity, or AUC would be relevant.

    Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval, not on detailed performance study outcomes typically associated with AI/ML device evaluations.

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