FDA 510(k) Application Details - K111004

Device Classification Name	System, Catheter Control, Steerable   More FDA Info for this Device
510(K) Number	K111004
Device Name	System, Catheter Control, Steerable
Applicant	HANSEN MEDICAL, INC. 800 EAST MIDDLEFIELD ROAD MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	KATE WHITIN Other 510(k) Applications for this Contact
Regulation Number	870.1290   More FDA Info for this Regulation Number
Classification Product Code	DXX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2011
Decision Date	05/29/2012
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