FDA 510(k) Application Details - K063723

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K063723
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	ABIOMED, INC. 22 CHERRY HILL DR. DANVERS, MA 01923 US Other 510(k) Applications for this Company
Contact	ROBERT T KUNG 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	12/15/2006
Decision Date	05/30/2008
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