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510(k) Data Aggregation

    K Number
    K251838

    Validate with FDA (Live)

    Device Name
    Introducer Sheath Set
    Manufacturer
    Cardiocycle Medical (Suzhou) Co.,Ltd
    Date Cleared
    2025-10-21

    (127 days)

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

    The Introducer Sheath set is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

    Device Description

    The Introducer Sheath Set consists of a sheath and a dilator. The sheath is comprised of a sheath tube, a sheath hub, and a hemostatic valve. While the dilator comprises a dilator hub, a dilator tube and a rod cap. The sheath features a hydrophilic coating. Each set of products is equipped with a sheath and a dilator. The product is sterilized with ethylene oxide and is disposable.

    AI/ML Overview

    N/A

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