EPISTAXIS CATHETER/KIT
Device Facts
| Record ID | K821584 |
|---|---|
| Device Name | EPISTAXIS CATHETER/KIT |
| Applicant | Bivona Medical Technologies |
| Product Code | EMX · Ear, Nose, Throat |
| Decision Date | Jun 14, 1982 |
| 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.