The following data is part of a premarket notification filed by Acclarent, Inc. with the FDA for Acclarent Aera Eustachian Tube Balloon Dilation System.
| Device ID | K171761 |
| 510k Number | K171761 |
| Device Name: | ACCLARENT AERA Eustachian Tube Balloon Dilation System |
| Classification | Eustachian Tube Balloon Dilation Device |
| Applicant | Acclarent, Inc. 33 Technology Drive Irvine, CA 92618 |
| Contact | James Patrick Garvey Ii |
| Correspondent | James Patrick Garvey Ii Acclarent, Inc. 33 Technology Drive Irvine, CA 92618 |
| Product Code | PNZ |
| CFR Regulation Number | 874.4180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-14 |
| Decision Date | 2018-01-16 |
| Summary: | summary |