EPISTAT-II NASAL CATHETER
Device Facts
| Record ID | K943718 |
|---|---|
| Device Name | EPISTAT-II NASAL CATHETER |
| Applicant | Merocel Corp. |
| Product Code | EMX · Ear, Nose, Throat |
| Decision Date | Sep 16, 1994 |
| 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.