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510(k) Data Aggregation

    K Number
    K253323
    Device Name
    Protrieve Sheath
    Manufacturer
    Date Cleared
    2025-10-29

    (29 days)

    Product Code
    Regulation Number
    870.5150
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ClotTriever Thrombectomy System is indicated for:

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

    The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).

    The Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

    Device Description

    The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC).

    AI/ML Overview

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