FDA 510(k) Application Details - K191446

Device Classification Name	Stent, Ureteral   More FDA Info for this Device
510(K) Number	K191446
Device Name	Stent, Ureteral
Applicant	Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Jois Zuniga Gamboa Other 510(k) Applications for this Contact
Regulation Number	876.4620   More FDA Info for this Regulation Number
Classification Product Code	FAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2019
Decision Date	01/02/2020
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review