The following data is part of a De Novo classification by Acclarent, Inc. with the FDA for Acclarent Aera Eustachian Tube Balloon Dilation System.
| DeNovo ID | DEN150056 |
| Device Name: | Acclarent Aera Eustachian Tube Balloon Dilation System |
| Classification | Eustachian Tube Balloon Dilation Device |
| Applicant | ACCLARENT, INC. 1525-b O'brien Dr. Menlo Park, CA 94025 |
| Contact | James Patrick Garvey |
| Product Code | PNZ |
| CFR Regulation Number | 874.4180 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Ear Nose & Throat |
| Classification Advisory | Ear Nose & Throat |
| Type | Direct |
| Date Received | 2015-12-07 |
| Decision Date | 2016-09-16 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031230870 | DEN150056 | 000 |
| 20705031230887 | DEN150056 | 000 |