FDA 510(k) Application Details - K201085

Device Classification Name	More FDA Info for this Device
510(K) Number	K201085
Device Name	NeVa PV Thrombectomy Device
Applicant	Vesalio 3200 West End Ave, Ste 500 Nashville, TN 37203 US Other 510(k) Applications for this Company
Contact	Gustavo Prado 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	04/23/2020
Decision Date	01/15/2021
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