FDA 510(k) Application Details - K152572

Device Classification Name	More FDA Info for this Device
510(K) Number	K152572
Device Name	AXIOS Stent and Delivery System
Applicant	BOSTON SCIENTIFIC CORPORATION 453 RAVENDALE DRIVE, SUITE H MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	ASHLEY SANTOS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2015
Decision Date	10/06/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review