| Device Type ID | 1434 |
| Device Name | Balloon, Epistaxis |
| Regulation Description | Epistaxis Balloon. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 874.4100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EMX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1434 |
| Device | Balloon, Epistaxis |
| Product Code | EMX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Epistaxis Balloon. |
| CFR Regulation Number | 874.4100 [🔎] |
| Device Problems | |
|---|---|
Material Rupture | 3 |
Air Leak | 1 |
Inflation Problem | 1 |
Balloon | 1 |
| Total Device Problems | 6 |