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Device Name
Sophy Mini Monopressure Valve (SM1)Manufacturer
Date Cleared
2025-11-28
(270 days)
Product Code
Regulation Number
882.5550Type
TraditionalPanel
NeurologyReference & 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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