FDA 510(k) Application Details - K061070

Device Classification Name	Trocar   More FDA Info for this Device
510(K) Number	K061070
Device Name	Trocar
Applicant	HANSEN MEDICAL, INC. 380 NORTH BERNARDO AVE. MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	NINA PELED Other 510(k) Applications for this Contact
Regulation Number	870.1390   More FDA Info for this Regulation Number
Classification Product Code	DRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2006
Decision Date	10/13/2006
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