Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4075](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4075) → MFY — Endothelial Cell Harvesting Kit

# MFY · Endothelial Cell Harvesting Kit

_Cardiovascular · 21 CFR 870.4075 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MFY

## Overview

- **Product Code:** MFY
- **Device Name:** Endothelial Cell Harvesting Kit
- **Regulation:** [21 CFR 870.4075](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4075)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K925608](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MFY/K925608.md) | SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT | Scimed Life Systems, Inc. | Jun 16, 1993 | SESK |

## Top Applicants

- Scimed Life Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MFY](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MFY)

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