FDA 510(k) Application Details - K212341

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K212341
Device Name	Oxygenator, 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	870.4350   More FDA Info for this Regulation Number
Classification Product Code	DTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2021
Decision Date	01/28/2022
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