FDA 510(k) Application Details - K202218

Device Classification Name	More FDA Info for this Device
510(K) Number	K202218
Device Name	ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
Applicant	Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 US Other 510(k) Applications for this Company
Contact	Vanessa Fowler Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2020
Decision Date	10/02/2020
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