Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4210](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4210) → OEU — Cardiopulmonary Bypass Catheter Kit

# OEU · Cardiopulmonary Bypass Catheter Kit

_Cardiovascular · 21 CFR 870.4210 · Class 2_

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

## Overview

- **Product Code:** OEU
- **Device Name:** Cardiopulmonary Bypass Catheter Kit
- **Regulation:** [21 CFR 870.4210](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4210)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

## 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/OEU](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/OEU)

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