Device typeCerebrospinal fluid shunt valve: An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.
FDA categoryCatheter, percutaneous, intraspinal, short term
Device ID00763000027858
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information