FDA 510(k) Application Details - K202751

Device Classification Name	More FDA Info for this Device
510(K) Number	K202751
Device Name	TandemHeart Pump and Escort Controller
Applicant	CardiacAssist, Inc. 620 Alpha Drive, Suite 2 Pittsburgh, PA 15238 US Other 510(k) Applications for this Company
Contact	Megan Walsh 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	09/21/2020
Decision Date	03/26/2021
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