FDA 510(k) Application Details - K250150

Device Classification Name	Heat-Exchanger, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K250150
Device Name	Heat-Exchanger, Cardiopulmonary Bypass
Applicant	Sorin Group Italia S.r.l. Via Statale 12 Nord, 86 Mirandola (Modena) 41037 IT Other 510(k) Applications for this Company
Contact	Martina Carlini 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	01/21/2025
Decision Date	05/30/2025
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