Gas Control Unit, Cardiopulmonary Bypass
The Cardiopulmonary Bypass Gas Control Unit is a life-sustaining cardiovascular device used to regulate the composition and flow of gas delivered to the oxygenator during extracorporeal bypass, controlling the oxygen and carbon dioxide content of blood returned to the patient. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTX and it is regulated under 21 CFR 870.4300 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.
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Basic Information
- Product Code
- DTX
- Device Class
- FDA class 2
- Regulation Number
- 870.4300
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K210669 | Quantum Mini Ventilation Module | May 04, 2021 | Substantially Equivalent | Spectrum Medical , Ltd. |
| K202733 | Quantum Ventilation Module | Oct 16, 2020 | Substantially Equivalent | Spectrum Medical , Ltd. |
| K181942 | Quantum Ventilation Module | Oct 18, 2018 | Substantially Equivalent | Spectrum Medical , Ltd. |
| K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | Dec 09, 2010 | Substantially Equivalent | Sorin Group Deutschland GmbH |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | Jan 17, 2003 | Substantially Equivalent | Sechrist Industries, Inc. |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | Mar 28, 1997 | Substantially Equivalent | Coeur Laboratories, Inc. |
| K863902 | MODIFIED SARNS MEMBRANE OXYGENATOR | Dec 11, 1986 | Substantially Equivalent | 3M Health Care, Sarns |
| K822820 | GAS-FLOW METER GFL 10 | Oct 18, 1982 | Substantially Equivalent | Gambro, Inc. |
| K792348 | STANICOR, OMNI-STAN,MOD 333B,334A GAMMA | Dec 05, 1979 | Substantially Equivalent | Cordis Corp. |
| K790546 | FLOWMETER, OPTIFLO GAS | May 11, 1979 | Substantially Equivalent | Cobe Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.