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Mri Interventions, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K200079ClearPoint System and AccessoriesFebruary 13, 2020
K191701Arcus Head Fixation FrameNovember 15, 2019
K191400Voyager Trajectory Array Guide (V-TAG)June 21, 2019
K181731MR Compatible Aspiration KitNovember 20, 2018
K181195ClearPoint SystemNovember 2, 2018
K171257ClearPoint SystemOctober 20, 2017
K160129MRII Cranial Drill and AccessoriesMarch 26, 2016
K160434ClearPoint SystemMarch 17, 2016
K142505ClearPoint SystemOctober 21, 2015
K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmJuly 8, 2015
K132436VARIOGUIDE DRILL KITMarch 20, 2014
K123605SMARTFLOW CATHETERAugust 16, 2013
K122456MRII CRAINIAL DRILLMarch 22, 2013
K111802SV BRAIN ARRAY, SIEMENS 3TSeptember 8, 2011