Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3925](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3925) → DYE — Replacement Heart-Valve

# DYE · Replacement Heart-Valve

_Cardiovascular · 21 CFR 870.3925 · Class 3_

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

## Overview

- **Product Code:** DYE
- **Device Name:** Replacement Heart-Valve
- **Regulation:** [21 CFR 870.3925](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3925)
- **Device Class:** 3
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Implant:** yes

## Identification

A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P010041](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P010041.md) | CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC) | Edwards Lifesciences, LLC | Jun 24, 2002 | APWD |
| [P000007](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P000007.md) | EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P | Edwards Lifesciences, LLC | Feb 27, 2001 | APWD |
| [P990064](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P990064.md) | MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE | Medtronic, Inc. | Jul 14, 2000 | APPR |
| [P980043](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P980043.md) | HANCOCK II PORCINE BIOPROSTHESIS | Medtronic, Inc. | Sep 28, 1999 | APPR |
| [P860057](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P860057.md) | EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES | Edwards Lifesciences, LLC | Sep 26, 1991 | APPR |
| [P870077](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P870077.md) | CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS | Edwards Lifesciences, LLC | Sep 25, 1991 | APWD |
| [P870056](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P870056.md) | CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625 | Edwards Lifesciences, LLC | Sep 25, 1991 | APWD |
| [P870078](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P870078.md) | HANCOCK PORCINE BIOPROSTHESIS | Medtronic, Inc. | Sep 28, 1989 | APPR |

## Top Applicants

- Edwards Lifesciences, LLC — 5 clearances
- Medtronic, Inc. — 3 clearances

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

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