FDA 510(k) Application Details - K232480

Device Classification Name	More FDA Info for this Device
510(K) Number	K232480
Device Name	ProtekDuo Veno-Venous Cannula Sets
Applicant	CardiacAssist, Inc. 620 Alpha Drive, Suite 2 Pittsburgh, PA 15238 US Other 510(k) Applications for this Company
Contact	Mariah McMinn Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2023
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