FDA 510(k) Application Details - K152225

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K152225
Device Name	Introducer, Catheter
Applicant	EDWARDS LIFESCIENCES 1 EDWARDS WAY IRVINE, CA 92614-5686 US Other 510(k) Applications for this Company
Contact	KAREN REYNOLDS 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	08/07/2015
Decision Date	11/24/2015
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