The following data is part of a premarket notification filed by Bivona Medical Technologies with the FDA for Epistaxis Catheter/kit.
| Device ID | K821584 |
| 510k Number | K821584 |
| Device Name: | EPISTAXIS CATHETER/KIT |
| Classification | Balloon, Epistaxis |
| Applicant | BIVONA MEDICAL TECHNOLOGIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-01 |
| Decision Date | 1982-06-14 |