DTX — Gas Control Unit, Cardiopulmonary Bypass Class II
FDA Device Classification
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 |