FDA 510(k) Application Details - K173586

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K173586
Device Name	Catheter, Continuous Flush
Applicant	Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Ye Seul Kim Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2017
Decision Date	04/05/2018
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