FDA 510(k) Application Details - K191402

Device Classification Name	Controller, Temperature, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K191402
Device Name	Controller, Temperature, Cardiopulmonary Bypass
Applicant	LivaNova Deutschland GmbH Lindberghstrasse 25 Munich 80939 DE 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	05/24/2019
Decision Date	02/25/2020
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