# LWQ · Heart-Valve, Mechanical

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/LWQ

## Overview

- **Product Code:** LWQ
- **Device Name:** Heart-Valve, Mechanical
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes
- **Life-sustaining:** yes

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P000037](/device/P000037.md) | ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA | On-X Life Technologies, Inc. | May 30, 2001 | APPR |
| [P990046](/device/P990046.md) | ATS OPEN PIVOT BILEAFLET HEART VALVE | Medtronic Ats Medical, Inc. | Oct 13, 2000 | APPR |
| [P970002](/device/P970002.md) | MONOSTRUT CARDIAC VALVE PROSTHESIS | Alliance Medical Technologies, Inc. | Sep 30, 1997 | APPR |
| [P900060](/device/P900060.md) | CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) | Corcym S.r.l. | Sep 29, 1993 | APPR |
| [P870038](/device/P870038.md) | STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES | Edwards Lifesciences, LLC | Sep 27, 1991 | APWD |
| [P850006](/device/P850006.md) | DUROMEDICS BILEAFLET HEART VALVE | Edwards Lifesciences, LLC | Aug 29, 1986 | APWD |
| [P830039](/device/P830039.md) | OMNISCEINCE PROSTHETIC CARDIAC VALVE | Medical Cv, Inc. | May 3, 1985 | APWD |
| [P810002](/device/P810002.md) | BILEAFLET-CENTER OPENING CARDIAC VALVE | ABBOTT MEDICAL | Dec 17, 1982 | APPR |
| [P790018](/device/P790018.md) | MEDTRONIC(R) HALL PROSTHETIC HEART VALVE | Medtronic Cardiac Surgery | Dec 23, 1981 | APWD |

## Top Applicants

- Edwards Lifesciences, LLC — 2 clearances
- ABBOTT MEDICAL — 1 clearance
- Alliance Medical Technologies, Inc. — 1 clearance
- Corcym S.r.l. — 1 clearance
- Medical Cv, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/LWQ](https://fda.innolitics.com/productcode/LWQ)

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