FDA 510(k) Application Details - K153501

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K153501
Device Name	Catheter, Continuous Flush
Applicant	MERCATOR MEDSYSTEMS, INC. 2200 POWELL STREET SUITE 530 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	12/07/2015
Decision Date	04/15/2016
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