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510(k) Data Aggregation

    K Number
    K211013
    Device Name
    FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
    Manufacturer
    Inari Medical, Inc.
    Date Cleared
    2021-04-30

    (25 days)

    Product Code
    QEW,KRA
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K201541,K202345
    Predicate For
    K213402,K223929
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FlowTriever Retrieval/Aspiration System is indicated for:

    • The non-surgical removal of emboli and thrombi from blood vessels.
    • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

    The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

    Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.

    Device Description

    The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
    • Triever Catheters (available in 3 sizes: 16, 20 (and 20 Curved) and 24 Fr)
    • FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
    Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After removal of its dilator, thrombus may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter is removed from the patient.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (FlowTriever Retrieval/Aspiration System) and describes updates to its indications for use. It is not a study report proving the device meets acceptance criteria through performance evaluation.

    Therefore, I cannot provide the requested information as the document does not contain a study that demonstrates device performance against specific acceptance criteria.

    The submission focuses on a modification to the contraindications for the device, specifically removing "chronic clot" from the examples of material not to be removed. The core of this 510(k) summary is to demonstrate that this change does not raise new questions of safety or effectiveness compared to the predicate device.

    The document explicitly states:

    • "Non-Clinical Testing Non-clinical testing was not required to support the change to the contraindications."
    • "Clinical Testing No clinical data was required to support the change to the contraindications."
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