510(k) DEN150056
DEN150056 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "Acclarent Aera Eustachian Tube Balloon Dilation System". The FDA issued a decision of De Novo Granted on September 16, 2016. The device falls under product code PNZ (Eustachian Tube Balloon Dilation Device), a Class II device regulated under 21 CFR 874.4180. Acclarent, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 16, 2016
- Date Received
- December 7, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eustachian Tube Balloon Dilation Device
- Device Class
- Class II
- Regulation Number
- 874.4180
- Review Panel
- EN
- Submission Type
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.