FDA 510(k) Application Details - K240584

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K240584
Device Name	Apparatus, Autotransfusion
Applicant	Sorin group Italia S.r.l. Via Statale 12 Nord, 86 Mirandola (Modena) 41037 IT Other 510(k) Applications for this Company
Contact	Luigi Vecchi Other 510(k) Applications for this Contact
Regulation Number	868.5830   More FDA Info for this Regulation Number
Classification Product Code	CAC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2024
Decision Date	04/29/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review