FDA 510(k) Application Details - K223898

Device Classification Name	More FDA Info for this Device
510(K) Number	K223898
Device Name	VitalFlowTM Centrifugal Pump
Applicant	Michigan Critical Care Consultants, Inc. (d.b.a MC3 Inc.) 2555 Bishop Circle West Dexter, MI 48130 US Other 510(k) Applications for this Company
Contact	Martha Rumford 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	12/28/2022
Decision Date	08/25/2023
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