FDA 510(k) Application Details - K083402

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K083402
Device Name	Introducer, Catheter
Applicant	ST. JUDE MEDICAL 14901 DEVEAU PL. MINNETONKA, MN 55345-2126 US Other 510(k) Applications for this Company
Contact	MAC MCKEEN 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	11/18/2008
Decision Date	12/15/2008
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