Vascular Insights, LLC

FDA Regulatory Profile

Vascular Insights, LLC appears in FDA public data with 1 recall, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1146-2018, Class II) was initiated on November 9, 2017. Its most recent 510(k) clearance was granted on January 6, 2016.

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