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510(k) Data Aggregation

    K Number
    K250636

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-28

    (270 days)

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

    The Sophy Mini Monopressure Valve is designed for the treatment of hydrocephalus by shunting cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.

    Device Description

    The Sophy® Mini Monopressure Valve is intended for the treatment of hydrocephalus by shunting the cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.

    The complete CSF shunting system provides shunting of CSF from the ventricular cavities in the brain to another part of the body where the CSF can be absorbed in blood.

    At the minimum, a complete CSF shunt consists of:

    • A proximal catheter to drain CSF from either lateral brain ventricles;
    • A distal catheter to drain CSF to a body cavity where it can be absorbed in blood (most often, the peritoneal cavity or the right atrium of the heart so respectively called peritoneal or atrial catheter also);
    • Between the two, a valve which regulates the flow of CSF.
    AI/ML Overview

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