Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3325](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3325) → QZU — Temporary Embolization Assist Device, Peripheral

# QZU · Temporary Embolization Assist Device, Peripheral

_Cardiovascular · 21 CFR 870.3325 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/QZU

## Overview

- **Product Code:** QZU
- **Device Name:** Temporary Embolization Assist Device, Peripheral
- **Regulation:** [21 CFR 870.3325](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3325)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

The BraidE Embolization Assist Device is a sterile, single-use, prescription endovascular device intended for temporary use in the peripheral vasculature to mechanically assist in the coil embolization of wide-necked peripheral aneurysms (neck width ≤ 10 mm, defined as > 4 mm or a dome-to-neck ratio < 2). The device consists of a nitinol braided mesh, stainless steel shaft, nitinol core wire, and a handle. It is delivered via an endovascular approach, is not intended for permanent implantation, and is removed upon procedure completion.

## Classification Rationale

Class II (special controls). The device is a temporary coil embolization assist device for peripheral vascular use, regulated under 21 CFR 870.3325.

## Special Controls

In combination with the general controls of the FD&C Act, the temporary coil embolization assist device for peripheral vascular use is subject to the following special controls:

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN230064](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/QZU/DEN230064.md) | BraidE Embolization Assist Device | Rapid Medical , Ltd. | Feb 21, 2024 | DENG |

## Top Applicants

- Rapid Medical , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/QZU](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/QZU)

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