FDA 510(k) Application Details - K220635

Device Classification Name	Controller, Temperature, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K220635
Device Name	Controller, Temperature, Cardiopulmonary Bypass
Applicant	LivaNova Deutschland GmbH Lindbergh Strasse 25 Munchen 80939 DE Other 510(k) Applications for this Company
Contact	Julia E. Leslie 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	03/04/2022
Decision Date	11/16/2022
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