FDA 510(k) Application Details - K212688

Device Classification Name	Heat-Exchanger, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K212688
Device Name	Heat-Exchanger, Cardiopulmonary Bypass
Applicant	Qura S.r.l. Via di Mezzo, 23 Mirandola 41037 IT Other 510(k) Applications for this Company
Contact	Raffaella Tommasini Other 510(k) Applications for this Contact
Regulation Number	870.4240   More FDA Info for this Regulation Number
Classification Product Code	DTR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2021
Decision Date	01/10/2022
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