FDA 510(k) Application Details - K102168

Device Classification Name	System, Catheter Control, Steerable   More FDA Info for this Device
510(K) Number	K102168
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	08/02/2010
Decision Date	10/22/2010
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