FDA 510(k) Application Details - DEN170004

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170004
Device Name	Ellipsys Vascular Access System
Applicant	Avenu Medical, Inc 27123 Calle Arroyo, Suite 2101 San Juan Capistrano, CA 92675 US Other 510(k) Applications for this Company
Contact	Rebecca K. Pine Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2017
Decision Date	06/22/2018
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review