(52 days)
The Accura Elite Shunt System is intended for use as the principle of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.
Not Found
This document is an FDA 510(k) clearance letter for the Accura Elite Shunt System, a Central Nervous System Fluid Shunt and Components. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device has been found substantially equivalent to a legally marketed predicate device and can therefore be marketed.
Therefore, I cannot provide the requested information.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
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.(b)
Classification. Class II (performance standards).