FDA 510(k) Application Details - K201792

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K201792
Device Name	Catheter, Continuous Flush
Applicant	Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 US Other 510(k) Applications for this Company
Contact	Aoife Tobin Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2020
Decision Date	07/28/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review