FDA 510(k) Application Details - K201076

Device Classification Name	More FDA Info for this Device
510(K) Number	K201076
Device Name	Anchor Dual Lumen Guidewire Catheter
Applicant	Aqure Medical, Inc. 12560 Flethcer Lane, Suite 300 Rogers, MN 55374 US Other 510(k) Applications for this Company
Contact	Jie Xia Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2020
Decision Date	08/06/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review