510(k) K153502

ClariVein IC by Vascular Insights, LLC — Product Code KRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2016
Date Received
December 7, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type