FDA 510(k) Application Details - K201068

Device Classification Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type   More FDA Info for this Device
510(K) Number	K201068
Device Name	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Applicant	Medtronic, Inc. 7611 Northland Drive Minneapolis, MN 55428 US Other 510(k) Applications for this Company
Contact	Sammie C. Joseph-Fredericks 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	04/22/2020
Decision Date	05/21/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review