FDA 510(k) Application Details - K202187

Device Classification Name	More FDA Info for this Device
510(K) Number	K202187
Device Name	FLEX Vessel Prep System
Applicant	VentureMed Group, Inc. 2800 Camput Drive, Suite 50 Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	Jill Schweiger Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2020
Decision Date	09/11/2020
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