Balloon, Nasal Airway
FDA product code QGK · Class I (low risk) · 21 CFR 874.4420 · Ear, Nose, Throat
The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183090 | Relieva Tract Balloon Dilation SystemQGK · Traditional | Acclarent, Inc. | 04/19/2019SE |