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510(k) Data Aggregation

    K Number
    K252509

    Validate with FDA (Live)

    Device Name
    AlphaVac Multipurpose Mechanical Aspiration System F1885
    Manufacturer
    Angio Dynamics, Inc.
    Date Cleared
    2025-11-24

    (108 days)

    Product Code
    QEZ
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K240397,K212392,K213402
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cannula is indicated for:

    • the non-surgical removal of thrombi or emboli from the vasculature
    • aspiration and injection of contrast media and other fluids from and into the vasculature

    The Cannula is intended for use in the venous system and for the treatment of pulmonary embolism.

    The Handle is indicated as a vacuum source for the AlphaVac Multipurpose Mechanical Aspiration System.

    The Sheath is intended to be inserted in the vasculature to provide a conduit for the insertion of the AlphaVac Cannula/Obturator and other endovascular devices while minimizing blood loss associated with such insertions.

    Device Description

    The AlphaVac Multipurpose Mechanical Aspiration (MMA) System is a single use-over-wire catheter-based system that facilitates the removal of thrombus, embolus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA Systems are comprised of six main components packaged together:

    • a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip
    • AlphaVac Sheath
    • AlphaVac Obturator
    • AlphaVac Handle
    • Collection Bags
    • AlphaVac Tubing

    The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e., Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag are connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured and contained within the waste bag for disposal. Target vessels include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), Right Heart (Atrium (RA)), and Pulmonary Artery Vasculature. The device is provided in ~85° angled configuration.

    AI/ML Overview

    N/A

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