# NKM · Mitral Valve Repair Devices

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/NKM

## Overview

- **Product Code:** NKM
- **Device Name:** Mitral Valve Repair Devices
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation.  These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P220003](https://fda.innolitics.com/submissions/CV/CV-misc/NKM/P220003.md) | PASCAL Precision Transcatheter Valve Repair System | Edwards Lifesciences, LLC | Sep 14, 2022 | APPR |
| [P100009](https://fda.innolitics.com/submissions/CV/CV-misc/NKM/P100009.md) | MITRACLIP DELIVERY SYSTEM | ABBOTT MEDICAL | Oct 24, 2013 | APPR |

## Top Applicants

- ABBOTT MEDICAL — 1 clearance
- Edwards Lifesciences, LLC — 1 clearance

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

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