Product code MWG
- Device name
- System, Oxygen, Aqueous
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P170027S018 | TherOx Downstream System | Zoll Circulation, Inc. | 2026-04-10 |
| P170027S020 | TherOx Downstream System | Zoll Circulation, Inc. | 2025-10-29 |
| P170027S019 | TherOx Downstream Cartridge | Zoll Circulation, Inc. | 2025-06-20 |
| P170027S017 | TherOx Downstream System | Zoll Circulation, Inc. | 2024-12-19 |
| P170027S016 | TherOx DownStream System | Zoll Circulation, Inc. | 2024-12-11 |
| P170027S014 | TherOx Downstream System | Zoll Circulation, Inc. | 2024-10-03 |
| P170027S015 | TherOx DownStream System | Zoll Circulation, Inc. | 2024-08-14 |
| P170027S012 | TherOx® DownStream® Cartridge (DSC-2) | Zoll Circulation, Inc. | 2024-06-06 |
| P170027S011 | TherOx Downstream System | Zoll Circulation, Inc. | 2024-06-06 |
| P170027S013 | TherOx Downstream System | Zoll Circulation, Inc. | 2024-04-25 |
| P170027S007 | TherOx Downstream System | Zoll Circulation, Inc. | 2023-10-20 |
| P170027S008 | TherOx Downstream System | Zoll Circulation, Inc. | 2023-03-09 |
| P170027S010 | TherOx Downstream Console | Zoll Circulation, Inc. | 2022-10-27 |
| P170027S009 | TherOx Downstream System | Zoll Circulation, Inc. | 2022-03-10 |
| P170027S006 | TherOx DownStream System | Zoll Circulation, Inc. | 2021-12-09 |
| P170027S005 | TherOx Downstream System | Zoll Circulation, Inc. | 2021-06-01 |
| P170027S004 | TherOx Downstream System | Zoll Circulation, Inc. | 2021-03-29 |
| P170027S003 | TherOx Downstream System | Zoll Circulation, Inc. | 2021-03-26 |
| P170027S001 | TherOx DownStream System | Zoll Circulation, Inc. | 2020-11-20 |
| P170027S002 | TherOx Downstream System | Zoll Circulation, Inc. | 2020-03-11 |
| P170027 | TherOx Downstream System | Zoll Circulation, Inc. | 2019-04-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00862478000421 | DownStream Cartridge | THEROX, INC. | 2019-08-08 |
| 00862478000438 | SSO2 Catheter | THEROX, INC. | 2019-08-08 |
| 00862478000445 | SSO2 Catheter | THEROX, INC. | 2019-08-08 |
| 00862478000452 | SSO2 Catheter | THEROX, INC. | 2019-08-08 |
| 00862478000469 | SSO2 Catheter | THEROX, INC. | 2019-08-08 |
| 00862478000407 | DownStream System | THEROX, INC. | 2019-08-08 |
| 00862478000414 | DownStream System | THEROX, INC. | 2019-08-08 |
| 10862478000428 | DownStream Cartridge | THEROX, INC. | 2019-08-08 |
| 20862478000432 | SSO2 Catheter | THEROX, INC. | 2019-08-08 |
| 20862478000449 | SSO2 Catheter | THEROX, INC. | 2019-08-08 |
| 20862478000456 | SSO2 Catheter | THEROX, INC. | 2019-08-08 |
| 20862478000463 | SSO2 Catheter | THEROX, INC. | 2019-08-08 |