FDA 510(k) Application Details - K153494

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K153494
Device Name	Introducer, Catheter
Applicant	ALSEAL 2, RUE DU PROFESSEUR MILLERET Besancon 25000 FR Other 510(k) Applications for this Company
Contact	Jean-Francois M Delforge 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	12/04/2015
Decision Date	08/25/2016
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