FDA 510(k) Application Details - K190473

Device Classification Name	Catheter, Pressure Monitoring, Cardiac   More FDA Info for this Device
510(K) Number	K190473
Device Name	Catheter, Pressure Monitoring, Cardiac
Applicant	ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Sherri Mellingen Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2019
Decision Date	09/13/2019
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