FDA 510(k) Application Details - K183490

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K183490
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	Medtronic Inc 7611 Northland Dr Minneapolis, MN 55428 US Other 510(k) Applications for this Company
Contact	Wendy Pinor Other 510(k) Applications for this Contact
Regulation Number	870.4350   More FDA Info for this Regulation Number
Classification Product Code	DTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2018
Decision Date	04/12/2019
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