NuVent Eustachian Tube Dilation Balloon— 510(k) K210841

Substantially Equivalent

Medtronic Xomed, Inc.

FDA 510(k) clearance K210841 for NuVent Eustachian Tube Dilation Balloon, Substantially Equivalent on 2021-08-16. Applicant: Medtronic Xomed, Inc..

Clearance details

Applicant: Medtronic Xomed, Inc.
Product code: Code PNZ
Advisory panel: Ear, Nose, Throat
Date received: 2021-03-22
Decision date: 2021-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

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