# OPR · Intrasaccular Flow Disruption Device

_ ·  · Class 3_

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

## Overview

- **Product Code:** OPR
- **Device Name:** Intrasaccular Flow Disruption Device
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

An intrasaccular flow disruption device is intended for use to treat wide-neck intracranial aneurysms in the neurovasculature through an endovascular approach.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P170032](https://fda.innolitics.com/submissions/NE/NE-misc/OPR/P170032.md) | Woven EndoBridge (WEB) Aneurysm Embolization System | MicroVention, Inc. | Dec 31, 2018 | APPR |

## Top Applicants

- MicroVention, Inc. — 1 clearance

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

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