FDA 510(k) Application Details - K121209

Device Classification Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line   More FDA Info for this Device
510(K) Number	K121209
Device Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant	Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. ELKTON, MD 21921 US Other 510(k) Applications for this Company
Contact	SUZANNE GRENIER Other 510(k) Applications for this Contact
Regulation Number	870.4260   More FDA Info for this Regulation Number
Classification Product Code	DTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2012
Decision Date	05/08/2012
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