FDA 510(k) Application Details - K133552

Device Classification Name	Catheter, Steerable   More FDA Info for this Device
510(K) Number	K133552
Device Name	Catheter, Steerable
Applicant	Hansen Medical 800 EAST MIDDLEFIELD ROAD MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	HASSAN LABAY 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	11/19/2013
Decision Date	02/07/2014
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