FDA 510(k) Application Details - DEN150040

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN150040
Device Name	WallFlex Biliary RX Fully Covered Stent System RMV
Applicant	BOSTON SCIENTIFIC 100 BOSTON SCIENTIFIC WAY MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	THOMAS HIRTE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2015
Decision Date	06/03/2016
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review