FDA 510(k) Application Details - K111972

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K111972
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	MEDTRONIC INC. 7611 NORTHLAND DRIVE MINNEAPOLIS, MN 55428 US Other 510(k) Applications for this Company
Contact	JESSICA SIXBERRY 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	07/11/2011
Decision Date	07/27/2011
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