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510(k) Data Aggregation

    K Number
    K251312
    Device Name
    Vesalio Peripheral System
    Manufacturer
    Vesalio Inc.
    Date Cleared
    2025-10-24

    (179 days)

    Product Code
    QEZ
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K213565,K193197
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K213565

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vesalio Peripheral Catheter is intended for use in the peripheral arterial vasculature for:

    • the removal of fresh, soft emboli and thrombi
    • infusion of diagnostic agents, such as contrast media
    Device Description

    The Vesalio Peripheral System consists of 1) Peripheral Catheter, 2) Peel away Introducer Sheath and 3) an Aspiration Tubing Set.

    The Peripheral Catheter is a single-lumen, coil-reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the peripheral arterial vasculature when connected to a compatible aspiration pump and the Aspiration Tubing Set.

    The catheter is a hollow cylindrical tube constructed using a combination of medical-grade polymers with metal reinforcement, a lubricous inner liner made from PTFE and the outer jacket consisting of thermoplastics made of polyurethane, polyether block amide, and nylon 12. The distal end of the catheter has a hydrophilic coating aimed to reduce friction and aid tracking through the vasculature. The catheter employs radiopaque characteristics for angiographic visualization.

    On the proximal end, the catheter incorporates a flexible strain relief, which provides kink resistance, and a translucent, polycarbonate female luer hub to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter.

    A peel-away introducer sheath is provided in the package to facilitate the insertion of the Peripheral Catheter's distal tip into an appropriate vascular sheath.

    The Aspiration Tubing Set is provided in a separate package and is made of common medical grade polymers. It comprises of a hollow cylindrical tube that is bonded to a standard male rotator fitting on one end. The male rotator allows the tubing to connect to an RHV or the female luer hub of the catheter. The other end of the tubing consists of a hose fitting to enable connection with a vacuum pump. A flow switch is connected in line to provide vacuum control. The Peripheral System is provided sterile, non-pyrogenic, and is intended for single use only.

    AI/ML Overview

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