FDA 510(k) Applications Submitted by MRI INTERVENTIONS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K151536 |
06/08/2015 |
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm |
MRI INTERVENTIONS, INC. |
| K142505 |
09/05/2014 |
ClearPoint System |
MRI INTERVENTIONS, INC. |
| K132436 |
08/05/2013 |
VARIOGUIDE DRILL KIT |
MRI INTERVENTIONS, INC. |
| K111802 |
06/27/2011 |
SV BRAIN ARRAY, SIEMENS 3T |
MRI INTERVENTIONS, INC. |
| K122456 |
08/13/2012 |
MRII CRAINIAL DRILL |
MRI INTERVENTIONS, INC. |
| K123605 |
11/21/2012 |
SMARTFLOW CATHETER |
MRI INTERVENTIONS, INC. |
| K171257 |
04/28/2017 |
ClearPoint System |
MRI Interventions, Inc. |
| K181195 |
05/04/2018 |
ClearPoint System |
MRI Interventions, Inc. |
| K191400 |
05/24/2019 |
Voyager Trajectory Array Guide (V-TAG) |
MRI Interventions, Inc. |
| K191701 |
06/25/2019 |
Arcus Head Fixation Frame |
MRI Interventions, Inc. |
| K181731 |
06/29/2018 |
MR Compatible Aspiration Kit |
MRI Interventions, Inc. |
| K160129 |
01/20/2016 |
MRII Cranial Drill and Accessories |
MRI INTERVENTIONS, INC. |
| K160434 |
02/16/2016 |
ClearPoint System |
MRI INTERVENTIONS, INC. |
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