FDA 510(k) Application Details - K101186

Device Classification Name	Defoamer, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K101186
Device Name	Defoamer, Cardiopulmonary Bypass
Applicant	MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. MINNEAPOLIS, MN 55432 US Other 510(k) Applications for this Company
Contact	CARALEE WALTON Other 510(k) Applications for this Contact
Regulation Number	870.4230   More FDA Info for this Regulation Number
Classification Product Code	DTP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2010
Decision Date	09/03/2010
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