FDA 510(k) Application Details - K133265

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K133265
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	WHITNEY TORNING Other 510(k) Applications for this Contact
Regulation Number	870.4360   More FDA Info for this Regulation Number
Classification Product Code	KFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2013
Decision Date	11/12/2013
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