FDA 510(k) Application Details - DEN230087

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230087
Device Name	AMStent« Tracheobronchial Covered Stent System
Applicant	Peytant Solutions, Inc. 3650 Annapolis Lane North, #180 Plymouth, MN 55447 US Other 510(k) Applications for this Company
Contact	John Schorgl Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2023
Decision Date	10/16/2024
Decision	DENG -
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review