FDA 510(k) Application Details - K170992

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K170992
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Siemens Medical Solutions USA, Inc 685 East Middlefield Road Mountain View, CA 94043 US Other 510(k) Applications for this Company
Contact	Shelly Pearce 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	04/03/2017
Decision Date	06/15/2017
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