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510(k) Data Aggregation

    K Number
    K252227
    Manufacturer
    Date Cleared
    2025-09-24

    (70 days)

    Product Code
    Regulation Number
    870.1340
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pounce™ Sheath is intended to introduce therapeutic or diagnostic devices into the vasculature.

    Device Description

    The Pounce™ Sheath 16Fr is a single-use, sterile introducer sheath intended for the introduction of therapeutic or diagnostic devices within the vasculature. The Pounce™ Sheath 16Fr includes the following features:

    • Braided nitinol, self-expanding funnel at the sheath's distal end
    • Handle assembly with slider button to actuate the funnel's deployment
    • Hub and hemostasis valve assembly to allow for device introduction and removal
    • Aspiration assembly including tubing, a stopcock, and connection for a 60 cc syringe

    Additional components provided within the packaging include:

    • 0.035" guidewire compatible pre-dilator for access site preparation
    • 0.035" guidewire compatible dilator designed for atraumatic introduction of the sheath
    • 60 cc locking syringe, compatible with the sheath's aspiration assembly

    A radiopaque marker band is located at the distal tip of the sheath during introduction and removal, when the funnel is sheathed. When the funnel is unsheathed, the radiopaque marker band is located proximally to the funnel. The funnel is sheathed and unsheathed with the actuation of a slider button located on the handle assembly. The hemostasis valve can be actively defeated (opened), during device introduction or removal, by pressing down on the base of the surrounding hub. This action is designed to minimize device contact across the hemostatic valve during the introduction or removal of devices. The aspiration assembly also aids in the delivery of contrast or saline.

    AI/ML Overview

    N/A

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