---
kind: "section"
citation: "21 C.F.R. § 882.4545"
title: "21"
number: "882.4545"
heading: "Shunt system implantation instrument."
url: "https://uscodex.org/cfr/21/882.4545"
---

# §882.4545. Shunt system implantation instrument.

- (a) **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.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 882.9](/cfr/21/882.9.md).

## Notes

### Amendments

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019]