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510(k) Data Aggregation

    K Number
    K992379
    Device Name
    RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
    Manufacturer
    RADIONICS, INC.
    Date Cleared
    1999-09-08

    (54 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K922941
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    As the proximal component for CSF drainage or monitoring from the lateral ventricles of the brain.

    Device Description

    The External Drainage Ventricular Catheter consists of a barium impregnated silicone tubing with flow holes at the distal end and a luer lock connector for attachment to an external drainage system. It is provided sterile for single use only.

    AI/ML Overview

    The provided text is a 510(k) summary for the Radionics XDC Ventricular Catheter. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study to prove the device meets specific acceptance criteria.

    Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The provided text primarily addresses regulatory classification, intended use, description of the device, and a comparison to predicate devices, which are typical components of a 510(k) submission. There is no mention of performance studies with specific statistical outcomes against acceptance criteria.

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