Vascular Insights, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1146-2018Class IIClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusioNovember 9, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K153502ClariVein ICJanuary 6, 2016
K071468CLARIVEIN CATHETERMarch 20, 2008