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    K Number
    K223266
    Device Name
    Hilzo Esophageal Stents
    Manufacturer
    Thoracent, Inc.
    Date Cleared
    2024-01-16

    (449 days)

    Product Code
    ESW
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    Thoracent, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HILZO Esophageal Stents are indicated for use in esophageal strictures caused by intrinsic malignant tumors.
    Device Description
    The HILZO Esophageal Stents are partially covered and fully covered, self-expanding tubular prosthesis designed to maintain patency of esophageal strictures. The HILZO Esophageal stents are available loaded on two styles of delivery devices, Over the Wire (OTW) and Through the Scope (TTS). The OTW delivery devices are 14Fr and the TTS is 10.5Fr to enable delivery through the working channel of an endoscope. The stents are made of Nitinol wire and are designed to prevent stent migration due to peristaltic motion and tumor in-growth. The stents are available in a variety models, diameters and lengths.
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