FDA 510(k) Application Details - K233091

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K233091
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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	870.4360   More FDA Info for this Regulation Number
Classification Product Code	KFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2023
Decision Date	10/26/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review