FDA 510(k) Application Details - K241352

Device Classification Name	Oxygenator, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K241352
Device Name	Oxygenator, Cardiopulmonary Bypass
Applicant	Medtronic Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	Kaitlin Cady 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	05/13/2024
Decision Date	06/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review