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510(k) Data Aggregation

    K Number
    K253106
    Device Name
    AngioVac Cannula
    Date Cleared
    2025-10-24

    (30 days)

    Product Code
    Regulation Number
    870.4210
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

    Device Description

    The AngioVac Cannula is a venovenous cannula with a nitinol basket reinforced, self-expandable funnel shaped distal tip collapsed using an over-sheath that can be advanced through a 26 Fr sheath and over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit, an AngioVac Circuit, a commercially available centrifugal pump and bubble trap. A commercially available reinfusion cannula is placed for venous return (typically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. The funnel tip is actuated by advancing the AngioVac Cannula out of the sheath deploying the self-expanding nitinol reinforced funnel shaped tip at the desired tip angle. Once optimal flow rate is achieved, the AngioVac Cannula is advanced under image guidance towards the undesirable intravascular (i.e. thrombus or emboli) until it is engaged, suctioned into the cannula and removed from the vasculature. The blood is then circulated though the filter and returned to the patient via the venous return cannula. A benefit of the AngioVac Cannula is that it allows for removal of thrombus and embolic material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. Target vessels for the thrombus/embolus extraction include but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Atrium (RA). The device is provided in ~20° (AngioVac C20) and ~180° (AngioVac C180) angled configurations.

    AI/ML Overview

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