FDA 510(k) Application Details - K040165

Device Classification Name	Catheter, Steerable   More FDA Info for this Device
510(K) Number	K040165
Device Name	Catheter, Steerable
Applicant	ST. JUDE MEDICAL 14901 DEVEAU PLACE MINNETONKA, MN 55345 US Other 510(k) Applications for this Company
Contact	GLENN JACQUES Other 510(k) Applications for this Contact
Regulation Number	870.1280   More FDA Info for this Regulation Number
Classification Product Code	DRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2004
Decision Date	05/12/2004
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