FDA 510(k) Application Details - K223905

Device Classification Name	More FDA Info for this Device
510(K) Number	K223905
Device Name	Vivio« LVEDP System
Applicant	Avicena, LLC 117 E. Colorado Blvd., Suite 510 Pasadena, CA 91105 US Other 510(k) Applications for this Company
Contact	Sean Brady Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2022
Decision Date	10/06/2023
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