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) → OFG — Ct Biopsy Tray

# OFG · Ct Biopsy Tray

_Cardiovascular · 21 CFR 870.4075 · Class 2_

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

## Overview

- **Product Code:** OFG
- **Device Name:** Ct Biopsy Tray
- **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 (0 of 0)

_No cleared devices on record._

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

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