Medical Device Manufacturer · US , Irvine , CA

Mri Interventions, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2011

Recent clearances: ClearPoint System and Accessories, Arcus Head Fixation Frame, Voyager Trajectory Array Guide (V-TAG)

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mri Interventions, Inc. Neurology ✕

13 devices

1-13 of 13

Cleared Feb 13, 2020

ClearPoint System and Accessories

Neurology · 30d

Cleared Nov 15, 2019

Arcus Head Fixation Frame

Neurology · 143d

Cleared Jun 21, 2019

Voyager Trajectory Array Guide (V-TAG)

Neurology · 28d

Cleared Nov 20, 2018

MR Compatible Aspiration Kit

Neurology · 144d

Cleared Nov 02, 2018

ClearPoint System

Neurology · 182d

Cleared Oct 20, 2017

ClearPoint System

Neurology · 175d

Cleared Mar 26, 2016

MRII Cranial Drill and Accessories

Neurology · 66d

Cleared Mar 17, 2016

ClearPoint System

Neurology · 30d

Cleared Oct 21, 2015

ClearPoint System

Neurology · 411d

Cleared Jul 08, 2015

SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm

Neurology · 30d

Cleared Mar 20, 2014

VARIOGUIDE DRILL KIT

Neurology · 227d

Cleared Aug 16, 2013

SMARTFLOW CATHETER

Neurology · 268d

Cleared Mar 22, 2013

MRII CRAINIAL DRILL

Neurology · 221d