# OUT · Intracranial Aneurysm Flow Diverter

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/NE-misc/OUT

## Overview

- **Product Code:** OUT
- **Device Name:** Intracranial Aneurysm Flow Diverter
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

Treatment of wide-necked and larger or giant intracranial aneurysms.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P180027](https://fda.innolitics.com/submissions/NE/NE-misc/OUT/P180027.md) | Flow Re-Direction Endoluminal Device (FRED®) System | MicroVention, Inc. | Dec 16, 2019 | APPR |
| [P170024](https://fda.innolitics.com/submissions/NE/NE-misc/OUT/P170024.md) | Surpass Streamline Flow Diverter | Stryker Neurovascular | Jul 13, 2018 | APPR |
| [P100018](https://fda.innolitics.com/submissions/NE/NE-misc/OUT/P100018.md) | PIPELINE EMBOLIZATION DEVICE | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Apr 6, 2011 | APPR |

## Top Applicants

- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — 1 clearance
- MicroVention, Inc. — 1 clearance
- Stryker Neurovascular — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/NE-misc/OUT](https://fda.innolitics.com/submissions/NE/NE-misc/OUT)

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