DEN150056 is an FDA 510(k) submission for the Acclarent Aera Eustachian Tube Balloon Dilation System. This device is classified as a Eustachian Tube Balloon Dilation Device (Class II - Special Controls, product code PNZ).
Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Not Cleared (DENG) decision on September 16, 2016.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4180. The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction..
| 510(k) Number | DEN150056 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 07, 2015 |
| Decision Date | September 16, 2016 |
| Days to Decision | 284 days |
| Submission Type | Direct |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | PNZ — Eustachian Tube Balloon Dilation Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4180 |
| Definition | The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction. |