FDA 510(k) Application Details - K050109

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K050109
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. MINNEAPOLIS, MN 55038 US Other 510(k) Applications for this Company
Contact	PREETI JAIN 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	01/18/2005
Decision Date	02/11/2005
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