FDA 510(k) Application Details - K233736

Device Classification Name	More FDA Info for this Device
510(K) Number	K233736
Device Name	LifeSPARC System
Applicant	CardiacAssist, Inc. 620 Alpha Drive Pittsburgh, PA 15238 US Other 510(k) Applications for this Company
Contact	Arielle Drummond Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2023
Decision Date	01/19/2024
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