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510(k) Data Aggregation

    K Number
    K252714

    Validate with FDA (Live)

    Device Name
    C-Lant Port
    Date Cleared
    2026-02-27

    (184 days)

    Product Code
    Regulation Number
    876.1500
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K210495

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

    The C-Lant Port is intended for use in a variety of endoscopic procedures to provide a port of entry into the abdominal and thoracic cavities.

    Device Description

    The C-Lant Port is a sterile, single-use access system comprised of a trocar and a port with a self-fixating element, designed to provide a secure and sealed port of entry into the thoracic or abdominal cavity during a variety of endoscopic procedures. The device incorporates a retractable blade trocar for controlled penetration, which automatically re-sheaths to reduce the risk of internal injury once the cavity is accessed. Upon withdrawal of the delivery system, an internal fixation element expands into a flower-like configuration that anchors the device against the inner wall, while an external fixation disk with a soft foam interface prevents over-insertion. The integrated iris sealing mechanism rotates to provide a hermetic seal around catheters or tubes up to and including 28Fr, allowing reliable drainage or instrument passage without leakage.

    AI/ML Overview

    N/A

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