FDA 510(k) Application Details - K221491

Device Classification Name	Control, Pump Speed, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K221491
Device Name	Control, Pump Speed, Cardiopulmonary Bypass
Applicant	APMTD, Inc. 226 Lowell Street, Unit B16 Wilmington, MA 01887 US Other 510(k) Applications for this Company
Contact	John Sasso Other 510(k) Applications for this Contact
Regulation Number	870.4380   More FDA Info for this Regulation Number
Classification Product Code	DWA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2022
Decision Date	02/03/2023
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