FDA 510(k) Application Details - K191175

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K191175
Device Name	Catheter, Ultrasound, Intravascular
Applicant	ACIST Medical Systems, Inc. 7905 Fuller Rd. Eden Prairie, MN 55344 US Other 510(k) Applications for this Company
Contact	Angela Johnson Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2019
Decision Date	06/27/2019
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