FDA 510(k) Application Details - K242092

Device Classification Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line   More FDA Info for this Device
510(K) Number	K242092
Device Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line
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	870.4260   More FDA Info for this Regulation Number
Classification Product Code	DTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2024
Decision Date	11/18/2024
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