FDA 510(k) Application Details - K161102

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K161102
Device Name	Introducer, Catheter
Applicant	ST JUDE MEDICAL, INC. 15900 VALLEY VIEW CT SYLMAR, CA 91342 US Other 510(k) Applications for this Company
Contact	Hassan Labay 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	04/19/2016
Decision Date	05/19/2016
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