FDA 510(k) Application Details - K161402

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K161402
Device Name	Catheter, Continuous Flush
Applicant	MERCATOR MEDSYSTEMS, INC. 1900 POWELL STREET SUITE 800 Emeryville, CA 94608 US Other 510(k) Applications for this Company
Contact	Kirk P. Seward Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2016
Decision Date	08/18/2016
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