Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4300](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4300) → DTX — Gas Control Unit, Cardiopulmonary Bypass

# DTX · Gas Control Unit, Cardiopulmonary Bypass

_Cardiovascular · 21 CFR 870.4300 · Class 2_

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

## Overview

- **Product Code:** DTX
- **Device Name:** Gas Control Unit, Cardiopulmonary Bypass
- **Regulation:** [21 CFR 870.4300](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4300)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Life-sustaining:** yes

## Identification

A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K210669](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K210669.md) | Quantum Mini Ventilation Module | Spectrum Medical , Ltd. | May 4, 2021 | SESE |
| [K202733](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K202733.md) | Quantum Ventilation Module | Spectrum Medical , Ltd. | Oct 16, 2020 | SESE |
| [K181942](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K181942.md) | Quantum Ventilation Module | Spectrum Medical , Ltd. | Oct 18, 2018 | SESE |
| [K101046](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K101046.md) | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | Sorin Group Deutschland GmbH | Dec 9, 2010 | SESE |
| [K023745](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K023745.md) | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | Sechrist Industries, Inc. | Jan 17, 2003 | SESE |
| [K965214](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K965214.md) | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | Coeur Laboratories, Inc. | Mar 28, 1997 | SESE |
| [K863902](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K863902.md) | MODIFIED SARNS MEMBRANE OXYGENATOR | 3M Health Care, Sarns | Dec 11, 1986 | SESE |
| [K822820](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K822820.md) | GAS-FLOW METER GFL 10 | Gambro, Inc. | Oct 18, 1982 | SESE |
| [K792348](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K792348.md) | STANICOR, OMNI-STAN,MOD 333B,334A GAMMA | Cordis Corp. | Dec 5, 1979 | SESE |
| [K790546](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTX/K790546.md) | FLOWMETER, OPTIFLO GAS | Cobe Laboratories, Inc. | May 11, 1979 | SESE |

## Top Applicants

- Spectrum Medical , Ltd. — 3 clearances
- Sorin Group Deutschland GmbH — 1 clearance
- Sechrist Industries, Inc. — 1 clearance
- Gambro, Inc. — 1 clearance
- Cordis Corp. — 1 clearance

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

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