21 CFR § 874.4100
Epistaxis balloon
June 25, 2020
(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 of this chapter subject to §874.9.
[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]
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