OPTYX
Device Facts
| Record ID | K904883 |
|---|---|
| Device Name | OPTYX |
| Applicant | Baxter Healthcare Corp |
| Product Code | JXG · Neurology |
| Decision Date | Jul 24, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5550 |
| Device Class | Class 2 |
Regulatory Classification
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.
