21 CFR 882.5550 — Shunt, Central Nervous System And Components

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5550

Identification

A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

Classification Rationale

Class II (performance standards).

Product Codes