FDA 510(k) Application Details - K201775

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K201775
Device Name	Catheter, Ultrasound, Intravascular
Applicant	NuVera Medical, Inc. 140 Knowles Dr. Los Gatos, CA 95032 US Other 510(k) Applications for this Company
Contact	Robert Nardelli Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2020
Decision Date	03/05/2021
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