DTX · Gas Control Unit, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4300 · Class 2
Overview
| Product Code | DTX |
|---|---|
| Device Name | Gas Control Unit, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4300 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Quantum Mini Ventilation Module | Spectrum Medical , Ltd. | May 4, 2021 | SESE |
| K202733 | Quantum Ventilation Module | Spectrum Medical , Ltd. | Oct 16, 2020 | SESE |
| K181942 | Quantum Ventilation Module | Spectrum Medical , Ltd. | Oct 18, 2018 | SESE |
| K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | Sorin Group Deutschland GmbH | Dec 9, 2010 | SESE |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | Sechrist Industries, Inc. | Jan 17, 2003 | SESE |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | Coeur Laboratories, Inc. | Mar 28, 1997 | SESE |
| K863902 | MODIFIED SARNS MEMBRANE OXYGENATOR | 3M Health Care, Sarns | Dec 11, 1986 | SESE |
| K822820 | GAS-FLOW METER GFL 10 | Gambro, Inc. | Oct 18, 1982 | SESE |
| K792348 | STANICOR, OMNI-STAN,MOD 333B,334A GAMMA | Cordis Corp. | Dec 5, 1979 | SESE |
| K790546 | 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
