PVL · Endoscopic Shunt Placement Kit
Neurology · 21 CFR 882.5550 · Class 2
Overview
| Product Code | PVL |
|---|---|
| Device Name | Endoscopic Shunt Placement Kit |
| Regulation | 21 CFR 882.5550 |
| Device Class | Class 2 |
| Review Panel | Neurology |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
