FDA 510(k) Application Details - K250199

Device Classification Name	More FDA Info for this Device
510(K) Number	K250199
Device Name	VitalFlow Console
Applicant	Medtronic Inc 7611 Northland Drive Minneapolis, MN 55428 US Other 510(k) Applications for this Company
Contact	Elizabeth Rose Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2025
Decision Date	05/20/2025
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