MODIFIED BIVONA EPISTAXIS CATHETER
Device Facts
| Record ID | K900583 |
|---|---|
| Device Name | MODIFIED BIVONA EPISTAXIS CATHETER |
| Applicant | Bivona Medical Technologies |
| Product Code | EMX · Ear, Nose, Throat |
| Decision Date | Aug 9, 1990 |
| 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.
