---
kind: "section"
citation: "21 C.F.R. § 874.4100"
title: "21"
number: "874.4100"
heading: "Epistaxis balloon."
url: "https://uscodex.org/cfr/21/874.4100"
---

# §874.4100. Epistaxis balloon.

- (a) **Identification.** An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.
- (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 [§ 874.9](/cfr/21/874.9.md).

## Notes

### Amendments

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]

### Authority

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

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]