FDA 510(k) Application Details - K140398

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K140398
Device Name	Introducer, Catheter
Applicant	EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 US Other 510(k) Applications for this Company
Contact	LUKE MEIDELL Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2014
Decision Date	03/19/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review