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510(k) Data Aggregation

    K Number
    K093830
    Device Name
    MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2011-03-03

    (444 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE ANGIOGRAPHIC CONTROL SYRINGE

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

    An angiographic syringe is a device that consists of a syringe which is used to inject contrast material into the heart, great vessels, and coronary arteries during angiographic or CT procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is an FDA 510(k) clearance letter for the "Medline Angiographic Control Syringe," which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and indications for use but does not include any performance study data or acceptance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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