EPISTAXIS NASAL PACK
Device Facts
| Record ID | K971000 |
|---|---|
| Device Name | EPISTAXIS NASAL PACK |
| Applicant | Invotec International, Inc. |
| Product Code | EMX · Ear, Nose, Throat |
| Decision Date | May 14, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4100 |
| Device Class | Class 1 |
Regulatory Classification
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.
