FDA 510(k) Application Details - K201320

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K201320
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	05/18/2020
Decision Date	11/03/2021
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