DeviceClearance

ACCLARENT AERA Eustachian Tube Balloon Dilation System— 510(k) K171761

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K171761 for ACCLARENT AERA Eustachian Tube Balloon Dilation System, Substantially Equivalent on 2018-01-16. Applicant: Acclarent, Inc..

Clearance details

Applicant
Acclarent, Inc.
Product code
Code PNZ
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvin, CA, US
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