Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4320](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4320) → JOR — Generator, Pulsatile Flow, Cardiopulmonary Bypass

# JOR · Generator, Pulsatile Flow, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4320 · Class 3_

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

## Overview

- **Product Code:** JOR
- **Device Name:** Generator, Pulsatile Flow, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4320](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4320)
- **Device Class:** 3
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator.

## Classification Rationale

Class III (premarket approval).

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

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