FDA 510(k) Application Details - K153376

Device Classification Name	Console, Heart-Lung Machine, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K153376
Device Name	Console, Heart-Lung Machine, Cardiopulmonary Bypass
Applicant	Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 US Other 510(k) Applications for this Company
Contact	Bryan Hann Other 510(k) Applications for this Contact
Regulation Number	870.4220   More FDA Info for this Regulation Number
Classification Product Code	DTQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2015
Decision Date	12/16/2015
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