FDA 510(k) Application Details - DEN140009

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140009
Device Name	AMIGO REMOTE CATHETER SYSTEM
Applicant	CATHETER ROBOTICS INC 500 INTERNATIONAL DRIVE SUITE 255 MOUNT OLIVE, NJ 07828 US Other 510(k) Applications for this Company
Contact	JENNIFER ENGLUND Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2014
Decision Date	12/18/2014
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review