FDA 510(k) Application Details - K212582

Device Classification Name	Catheter, Biliary, Surgical   More FDA Info for this Device
510(K) Number	K212582
Device Name	Catheter, Biliary, Surgical
Applicant	Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Laura Kuroski Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	GCA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2021
Decision Date	05/06/2022
Decision	SESE - SUBST EQUIV
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