FDA 510(k) Application Details - K231652

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K231652
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	Sorin Group Italia S.R.L. Via Statale 12 Nord, 86 Mirandola 41037 IT Other 510(k) Applications for this Company
Contact	Luigi Vecchi 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	06/06/2023
Decision Date	11/16/2023
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