FDA Device Entity Profile: ACCLARENT, INC.

Known Identifiers & Locations

FEI Numbers 3005172759

Owner Operator Numbers 9068915

Locations Covered Irvine, CA, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3005172759	ACCLARENT, INC.	Irvine, CA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K171761	ACCLARENT AERA Eustachian Tube Balloon Dilation System	2018-01-16	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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