FDA 510(k) Application Details - K140012

Device Classification Name	Controller, Temperature, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K140012
Device Name	Controller, Temperature, Cardiopulmonary Bypass
Applicant	SORIN GROUP DEUTSCHLAND GMBH 14401 W 65TH WAY ARVADA, CO 80004 US Other 510(k) Applications for this Company
Contact	SCOTT LIGHT Other 510(k) Applications for this Contact
Regulation Number	870.4250   More FDA Info for this Regulation Number
Classification Product Code	DWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2014
Decision Date	01/31/2014
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