FDA 510(k) Application Details - K240666

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K240666
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 US Other 510(k) Applications for this Company
Contact	Megan Schlichting 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	03/08/2024
Decision Date	07/10/2024
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