DTX — Gas Control Unit, Cardiopulmonary Bypass Class II
FDA product code DTX covers "Gas Control Unit, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4300. Submissions are reviewed by the Cardiovascular panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTX
- Device Class
- Class II
- Regulation Number
- 870.4300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K210669 | spectrum medical | Quantum Mini Ventilation Module | May 4, 2021 |
| K202733 | spectrum medical | Quantum Ventilation Module | October 16, 2020 |
| K181942 | spectrum medical | Quantum Ventilation Module | October 18, 2018 |
| K101046 | sorin group deutschland | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | December 9, 2010 |
| K023745 | sechrist industries | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | January 17, 2003 |
| K965214 | coeur laboratories | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | March 28, 1997 |
| K863902 | 3m health care, sarns | MODIFIED SARNS MEMBRANE OXYGENATOR | December 11, 1986 |
| K822820 | gambro | GAS-FLOW METER GFL 10 | October 18, 1982 |
| K792348 | cordis | STANICOR, OMNI-STAN,MOD 333B,334A GAMMA | December 5, 1979 |
| K790546 | cobe laboratories | FLOWMETER, OPTIFLO GAS | May 11, 1979 |