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510(k) Data Aggregation

    K Number
    K243789
    Date Cleared
    2025-09-04

    (269 days)

    Product Code
    Regulation Number
    870.1290
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LIBERTY® Endovascular Robotic System is intended for use in the remote delivery and manipulation of guidewires and catheters, and remote manipulation of guide catheters, to facilitate navigation to anatomical targets in the peripheral vasculature.

    The LIBERTY® Endovascular Robotic System is not intended for coronary or neurointerventional procedures.

    Device Description

    The LIBERTY® Endovascular Robotic System (LIBERTY System) is a single-use, sterile, disposable device designed to help physicians navigate guidewires and catheters in peripheral endovascular procedures. It allows physicians to control the devices remotely using a handheld controller while enabling a physician to remain seated and away from the X-ray radiation source, thus reducing radiation exposure.

    Key components:

    • Bedside Robotic Drive: This motorized unit grips and maneuvers the interventional devices.
    • Handheld Remote Control: This wireless controller allows the physician to remotely advance, retract, and rotate the guidewire and microcatheter by communicating with the Robotic Drive.
    • Mounting Arm: This arm securely attaches the Robotic Drive to the patient's bed near the insertion point.
    • Accessories: These include hemostatic valves and an extension tube for managing fluids during the procedure.

    The system is intended to be used in peripheral endovascular procedures. Following manual insertion of an introducer sheath and guide catheter, the system is utilized via the handheld remote control that operates the robotic drive from a distance and enables remote positioning of guidewire and catheter (microcatheter) devices at a desired point inside the peripheral vasculature. Once the interventional devices are placed at the target site using the LIBERTY Robotic System, the devices are used manually consistent with their cleared indications for use for the interventional procedure.

    AI/ML Overview

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