Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3935](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3935) → MOP — Rotator, Prosthetic Heart Valve

# MOP · Rotator, Prosthetic Heart Valve

_Cardiovascular · 21 CFR 870.3935 · Class 1_

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

## Overview

- **Product Code:** MOP
- **Device Name:** Rotator, Prosthetic Heart Valve
- **Regulation:** [21 CFR 870.3935](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3935)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.

## Classification Rationale

Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K980016](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/MOP/K980016.md) | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | Genzyme Surgical Product (Genzyme Biosurgery) | Aug 7, 1998 | SESE |
| [K974648](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/MOP/K974648.md) | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | Sulzer Carbomedics, Inc. | Aug 4, 1998 | SESE |
| [K960923](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/MOP/K960923.md) | CARBOMEDICS MITRAL ROTATOR | Carbomedics, Inc. | Apr 29, 1996 | SESE |
| [K951368](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/MOP/K951368.md) | CARBOMEDICS EXENDED MITRAL ROTATOR | Carbomedics, Inc. | Jun 20, 1995 | SESE |

## Top Applicants

- Carbomedics, Inc. — 2 clearances
- Genzyme Surgical Product (Genzyme Biosurgery) — 1 clearance
- Sulzer Carbomedics, Inc. — 1 clearance

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

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