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510(k) Data Aggregation

    K Number
    K252309

    Validate with FDA (Live)

    Device Name
    PerQseal Introducers
    Manufacturer
    Vivasure Medical Limited
    Date Cleared
    2025-10-23

    (91 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K171866
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PerQseal Introducer: The PerQseal Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

    PerQseal Elite Introducer: The PerQseal Elite Introducers are intended to provide access and facilitate the insertion of diagnostic or endovascular devices into femoral vasculature.

    Device Description

    Each PerQseal Introducer ('S', 'L', Elite 14F, and Elite 18F) includes an Introducer Sheath with a Dilator positioned within the lumen. The Introducer Sheath comprises a simple sheath that provides access to the site, while the Dilator is a component which guides the Introducer Sheath to the access site and provides a blood signal that is used to ensure proper positioning of the Introducer Sheath.

    AI/ML Overview

    N/A

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