PIY · Stainless Steel Instrument, Shunt System Implantation
Neurology · 21 CFR 882.4545 · Class 1
Overview
| Product Code | PIY |
|---|---|
| Device Name | Stainless Steel Instrument, Shunt System Implantation |
| Regulation | 21 CFR 882.4545 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Cleared Devices (0)
No cleared devices on record.
