FDA 510(k) Application Details - K111092

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K111092
Device Name	Introducer, Catheter
Applicant	ST. JUDE MEDICAL 14901 DEVEAU PL. MINNETONKA, MN 55345-2126 US Other 510(k) Applications for this Company
Contact	VENKATA DAMARAJU 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	04/19/2011
Decision Date	06/09/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review