FDA 510(k) Application Details - K153502

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K153502
Device Name	Catheter, Continuous Flush
Applicant	VASCULAR INSIGHTS, LLC 1 PINE HILL DRIVE, TWO BATTERYMARCH PARK, SUITE 100 QUINCY, MA 02169 US Other 510(k) Applications for this Company
Contact	LORRAINE M. HANLEY 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	01/06/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review