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)

Total

Cleared

Denied

Mri Interventions, Inc. has 14 FDA 510(k) cleared neurology devices. Based in Irvine, US.

Historical record: 14 cleared submissions from 2011 to 2020.

Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant.

Mri Interventions, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

14 devices

1-12 of 14

Cleared Feb 13, 2020

ClearPoint System and Accessories

K200079 · HAW

Neurology · 30d

Cleared Nov 15, 2019

Arcus Head Fixation Frame

K191701 · HBL

Neurology · 143d

Cleared Jun 21, 2019

Voyager Trajectory Array Guide (V-TAG)

K191400 · HAW

Neurology · 28d

Cleared Nov 20, 2018

MR Compatible Aspiration Kit

MRII Cranial Drill and Accessories

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

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

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

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