FDA 510(k) Application Details - K161287

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K161287
Device Name	Catheter, Intravascular, Diagnostic
Applicant	MEDTRONIC VASCULAR 37A CHERRY HILL DR DANVERS, MA 01923 US Other 510(k) Applications for this Company
Contact	Nisarg Shah Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2016
Decision Date	08/19/2016
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review