FDA 510(k) Application Details - K161361

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K161361
Device Name	Catheter, Peripheral, Atherectomy
Applicant	Medtronic Vascular, Inc. (formerly d.b.a ev3 Inc., Covidien llc) 3033 Campus Drive Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	Rupali Gupta Other 510(k) Applications for this Contact
Regulation Number	870.4875   More FDA Info for this Regulation Number
Classification Product Code	MCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2016
Decision Date	10/14/2016
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	N
Expedited Review