Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3470](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3470) → MFX — Vessel Guard Or Cover, To Facilitate Revision Surgeries

# MFX · Vessel Guard Or Cover, To Facilitate Revision Surgeries

_Cardiovascular · 21 CFR 870.3470 · Class 2_

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

## Overview

- **Product Code:** MFX
- **Device Name:** Vessel Guard Or Cover, To Facilitate Revision Surgeries
- **Regulation:** [21 CFR 870.3470](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3470)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K061727](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/MFX/K061727.md) | GORE PRECLUDE VESSEL GUARD | W. L. Gore & Associates, Inc. | Aug 7, 2006 | SESE |
| [K960532](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/MFX/K960532.md) | PRECLUDE IMA SLEEVE | W. L. Gore & Associates, Inc. | May 23, 1996 | SESE |

## Top Applicants

- W. L. Gore & Associates, Inc. — 2 clearances

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

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