FDA 510(k) Application Details - K160121

Device Classification Name	System, Catheter Control, Steerable   More FDA Info for this Device
510(K) Number	K160121
Device Name	System, Catheter Control, Steerable
Applicant	Corindus, Inc. 309 Waverley Oaks Road, Suite 105 Waltham, MA 02454 US Other 510(k) Applications for this Company
Contact	Michael Douglas 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	01/19/2016
Decision Date	10/27/2016
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