FDA 510(k) Application Details - K191060

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K191060
Device Name	Injector And Syringe, Angiographic
Applicant	ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 35344 US Other 510(k) Applications for this Company
Contact	Matthew D. Stepanek Other 510(k) Applications for this Contact
Regulation Number	870.1650   More FDA Info for this Regulation Number
Classification Product Code	DXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2019
Decision Date	07/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review