FDA 510(k) Application Details - K223168

Device Classification Name	More FDA Info for this Device
510(K) Number	K223168
Device Name	Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with BalanceÖ Biosurface
Applicant	Medtronic Inc. 8200 Coral Sea St. NE Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	Anna Wetherille Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2022
Decision Date	04/19/2023
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