FDA 510(k) Application Details - K223633

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K223633
Device Name	Catheter, Percutaneous
Applicant	Boston Scientific Corporation One Scimed Place Maple Grove Maple Grove, MN 55311-1566 US Other 510(k) Applications for this Company
Contact	Mary-Jo Foley Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2022
Decision Date	08/08/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review