FDA 510(k) Application Details - K122488

Device Classification Name	System, Catheter Control, Steerable   More FDA Info for this Device
510(K) Number	K122488
Device Name	System, Catheter Control, Steerable
Applicant	CATHETER ROBOTICS INC 500 INTERNATIONAL DRIVE MOUNT OLIVE, NJ 07828 US Other 510(k) Applications for this Company
Contact	JENNIFER ENGLUND 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	08/15/2012
Decision Date	11/20/2012
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