FDA 510(k) Application Details - K210841

Device Classification Name	More FDA Info for this Device
510(K) Number	K210841
Device Name	NuVent Eustachian Tube Dilation Balloon
Applicant	Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 US Other 510(k) Applications for this Company
Contact	Matthew Harmon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2021
Decision Date	08/16/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review