FDA 510(k) Application Details - K161733

Device Classification Name	Reservoir, Blood, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K161733
Device Name	Reservoir, Blood, Cardiopulmonary Bypass
Applicant	Sorin Group Italia S.r.l 86, Via Statale 12 Nord Mirandola 41037 IT Other 510(k) Applications for this Company
Contact	Luigi Vecchi Other 510(k) Applications for this Contact
Regulation Number	870.4400   More FDA Info for this Regulation Number
Classification Product Code	DTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/2016
Decision Date	03/08/2017
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