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    K Number
    K251767
    Device Name
    Vena MicroAngioscope™ System
    Manufacturer
    Vena Medical Holdings Corp
    Date Cleared
    2025-10-01

    (113 days)

    Product Code
    LYK
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K911278
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vena MicroAngioscope™ System is indicated for the observation of the interior of blood vessels of the peripheral vasculature.

    Device Description

    The Vena MicroAngioscope System consists of two main components: the Vena MicroAngioscope™ (MA) and the Vena Camera Control Unit (CCU).

    The Vena MA is a full-color, forward-viewing, imaging angioscope intended to be used in conjunction with fluoroscopy to aid in vascular interventions. Designed to be used either with a parent catheter or balloon irrigation, it has a working length of 160 cm with a diameter of 3 French (0.040") at the distal tip and 2.7 French (0.036") at the proximal end. A radiopaque marker band is positioned at the distal tip of the device. The device features a lighting system surrounding a high-resolution video endoscope which provides real-time, high-resolution imaging inside blood vessels. This allows for direct, accurate visualization of vascular structures and pathologies, enabling precise interventions. The proximal end consists of a bifurcated joint for connection to an LED illumination source and a camera connector of the Vena CCU. This angioscope must be connected to the Vena CCU to acquire images and emit light. The Vena MicroAngioscope is the sterile, single use applied part of the Vena MicroAngioscope System.

    The Vena CCU is a compact, reusable imaging processor designed to interface with the MA to provide power, process images, and output live video. Housed in a durable metal enclosure, the CCU features a front panel interface with a dedicated camera connector for enabling visualization and an LED connector for powering the integrated illumination system. The unit includes two control buttons: one for capturing still images and another for recording video. The CCU requires the Vena MicroAngioscope to be attached to the front connectors for operation. Real-time imaging is transmitted via an HDMI output, allowing seamless integration with external monitors, while a USB port enables image and video storage. To maintain sterility in the angiosuite, the CCU is designed to be fully draped during procedures. Additionally, the CCU can be grounded by connecting to the equipotential grounding pin. By providing high-quality image processing and intuitive controls, the Vena CCU enables enhanced visualization and procedural efficiency in vascular interventions.

    AI/ML Overview

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