FDA 510(k) Application Details - K191114

Device Classification Name	More FDA Info for this Device
510(K) Number	K191114
Device Name	Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle
Applicant	Avenu Medical 27123 Calle Arroyo, Suite 2101 San Juan Capistrano, CA 92675 US Other 510(k) Applications for this Company
Contact	Dave Campbell 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	04/26/2019
Decision Date	08/09/2019
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