Product code DTX
- Device name
- Gas Control Unit, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4300
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210669 | Quantum Mini Ventilation Module | Spectrum Medical , Ltd. | 2021-05-04 |
| K202733 | Quantum Ventilation Module | Spectrum Medical , Ltd. | 2020-10-16 |
| K181942 | Quantum Ventilation Module | Spectrum Medical , Ltd. | 2018-10-18 |
| K101046 | STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM | Sorin Group Deutschland GmbH | 2010-12-09 |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | Sechrist Industries, Inc. | 2003-01-17 |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | Coeur Laboratories, Inc. | 1997-03-28 |
| K863902 | MODIFIED SARNS MEMBRANE OXYGENATOR | 3M Health Care, Sarns | 1986-12-11 |
| K822820 | GAS-FLOW METER GFL 10 | Gambro, Inc. | 1982-10-18 |
| K792348 | STANICOR, OMNI-STAN,MOD 333B,334A GAMMA | Cordis Corp. | 1979-12-05 |
| K790546 | FLOWMETER, OPTIFLO GAS | Cobe Laboratories, Inc. | 1979-05-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060434421890 | Quantum | SPECTRUM MEDICAL LIMITED | 2024-07-26 |
| 05060434421906 | Quantum | SPECTRUM MEDICAL LIMITED | 2024-02-27 |
| 05060434423832 | Quantum | SPECTRUM MEDICAL LIMITED | 2022-10-25 |
| 05060434423818 | Quantum | SPECTRUM MEDICAL LIMITED | 2022-10-25 |
| 15060434423815 | Quantum | SPECTRUM MEDICAL LIMITED | 2022-10-25 |
| 15060434423839 | Quantum | SPECTRUM MEDICAL LIMITED | 2022-10-25 |
| 05060434422842 | Quantum | SPECTRUM MEDICAL LIMITED | 2021-09-16 |
| 05060434422859 | Quantum | SPECTRUM MEDICAL LIMITED | 2021-09-16 |
| 05060434422699 | Quantum | SPECTRUM MEDICAL LIMITED | 2021-09-16 |
| 05060434422347 | Quantum | SPECTRUM MEDICAL LIMITED | 2021-05-06 |
| 05060434422514 | Quantum | SPECTRUM MEDICAL LIMITED | 2021-05-06 |
| 05060434422798 | Quantum | SPECTRUM MEDICAL LIMITED | 2021-05-06 |
| 05060434422064 | Quantum | SPECTRUM MEDICAL LIMITED | 2020-12-10 |
| 05060434422071 | Quantum | SPECTRUM MEDICAL LIMITED | 2020-12-10 |
| 05060434422736 | Quantum | SPECTRUM MEDICAL LIMITED | 2020-12-10 |
| 05060434422743 | Quantum | SPECTRUM MEDICAL LIMITED | 2020-12-10 |
| 05060434420879 | Quantum | SPECTRUM MEDICAL LIMITED | 2019-04-03 |
| 05060434420688 | Quantum | SPECTRUM MEDICAL LIMITED | 2019-01-14 |
| 04033817900702 | Electronic Gas Blender | LivaNova Deutschland GmbH | 2015-10-20 |
| 04033817900696 | Electronic Gas Blender | LivaNova Deutschland GmbH | 2015-10-16 |
| 04033817900719 | Electronic Gas Blender | LivaNova Deutschland GmbH | 2015-10-14 |