FDA 510(k) Application Details - K152310

Device Classification Name	Catheter, Steerable   More FDA Info for this Device
510(K) Number	K152310
Device Name	Catheter, Steerable
Applicant	CARDIOFOCUS, INC. 500 NICKERSON ROAD SUITE 500-200 MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	Seema Paliwal 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	08/14/2015
Decision Date	02/24/2016
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