FDA 510(k) Application Details - K200091

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K200091
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103 US Other 510(k) Applications for this Company
Contact	John Chesney Other 510(k) Applications for this Contact
Regulation Number	870.4360   More FDA Info for this Regulation Number
Classification Product Code	KFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2020
Decision Date	11/18/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review