FDA 510(k) Application Details - K203004

Device Classification Name	Injector And Syringe, Angiographic   More FDA Info for this Device
510(K) Number	K203004
Device Name	Injector And Syringe, Angiographic
Applicant	ACIST Medical Systems, Inc. 7905 Fuller Rd Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Jeff Koll 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	10/01/2020
Decision Date	12/17/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review