FDA 510(k) Application Details - K162384

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K162384
Device Name	Catheter, Percutaneous
Applicant	Medtronic Vascular, Inc.(formerly ev3 Inc.) 3033 Campus Dr Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	David Robertson Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2016
Decision Date	09/22/2016
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	Y
Expedited Review