FDA 510(k) Application Details - K161183

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K161183
Device Name	Introducer, Catheter
Applicant	C.R. BARD, INC MOYNE UPPER ENNISCORTHY IE Other 510(k) Applications for this Company
Contact	FIONA NI MHULLAIN 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	04/27/2016
Decision Date	06/03/2016
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	Y
Expedited Review