21 CFR 874.4100 — Balloon, Epistaxis
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4100
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.
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 § 874.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EMX | Balloon, Epistaxis | 1 | 47 |
