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510(k) Data Aggregation

    K Number
    K970983
    Device Name
    PERITONEAL/CARDIAC CATHETER
    Manufacturer
    INTEGRA NEUROCARE LLC.
    Date Cleared
    1997-06-13

    (87 days)

    Product Code
    JXG,84J
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Peritoneal/Cardiac Catheter is utilized in the treatment of hydrocephalic patients. It is a component in systems designed to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into either the peritoneal cavity of the right atrium of the heart. A ventriculoperitoneal shunting system may be indicated to avoid the cardiovascular complications of an atrial shunt or for a hydrocephalic patient in whom an atrial shunt is contraindicated.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria. It is a 510(k) clearance letter for a Peritoneal/Cardiac Hydrocephalic Shunt Catheter, indicating that the device has been found substantially equivalent to a predicate device.

    Therefore, I cannot populate the requested table and information based on the provided text. The document refers to the "indications for use" as being in an enclosure, but the enclosure itself is not provided. There is no mention of performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment.

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