Product code QQK
- Device name
- Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The device is intended for machine preservation of donor livers prior to transplantation.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P200035S033 | OrganOx metra® System | Organox Limited | 2026-05-21 |
| P200031S013 | Organ Care System (OCS™) Liver | TransMedics, Inc. | 2026-05-13 |
| P200035S036 | OrganOx metra® System | Organox Limited | 2026-04-10 |
| P200035S035 | OrganOx metra® System | Organox Limited | 2026-03-30 |
| P200035S032 | OrganOx metra® System | Organox Limited | 2026-03-16 |
| P200031S014 | Organ Care System (OCS™) Liver | TransMedics, Inc. | 2026-03-09 |
| P200035S031 | OrganOx metra® System | Organox Limited | 2025-12-17 |
| P200031S012 | Organ Care System™ (OCS™) Liver | TransMedics, Inc. | 2025-12-16 |
| P200031S011 | Organ Care System™ (OCS™) Liver | TransMedics, Inc. | 2025-10-22 |
| P200035S030 | OrganOx metra® System | Organox Limited | 2025-09-19 |
| P200035S029 | OrganOx metra® System | Organox Limited | 2025-09-08 |
| P200035S028 | OrganOx metra® System | Organox Limited | 2025-08-28 |
| P200035S026 | OrganOx metra System | Organox Limited | 2025-08-22 |
| P200035S025 | OrganOx metra® System | Organox Limited | 2025-08-20 |
| P200035S027 | OrganOx metra® System | Organox Limited | 2025-07-18 |
| P200035S024 | OrganOx metra System | Organox Limited | 2025-07-01 |
| P200031S010 | Organ Care System™ (OCS™) Liver | TransMedics, Inc. | 2025-07-01 |
| P200035S022 | OrganOx metra System | Organox Limited | 2025-06-10 |
| P200035S019 | OrganOx metra® System | Organox Limited | 2025-06-02 |
| P200035S018 | OrganOx metra System | Organox Limited | 2025-04-16 |
| P200035S023 | OrganOx metra System | Organox Limited | 2025-04-15 |
| P200035S021 | OrganOx metra System | Organox Limited | 2025-02-28 |
| P200031S007 | Organ Care System (OCS™) Liver | TransMedics, Inc. | 2025-01-13 |
| P200035S020 | OrganOx metra System | Organox Limited | 2024-12-17 |
| P200031S009 | Organ Care System™ (OCS™) Liver | TransMedics, Inc. | 2024-10-11 |
| P200035S015 | OrganOx metra System | Organox Limited | 2024-09-26 |
| P200035S017 | OrganOx metra® System | Organox Limited | 2024-09-09 |
| P200035S016 | OrganOx metra System | Organox Limited | 2024-08-23 |
| P200035S004 | OrganOx metra® System | Organox Limited | 2024-08-22 |
| P200035S014 | OrganOx metra® System | Organox Limited | 2024-03-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16945630123075 | Sterilance Soft Lancet 26G | Sterilance Medical (Suzhou) Inc. | 2024-01-15 |
| 36945630123079 | Sterilance Soft Lancet 26G | Sterilance Medical (Suzhou) Inc. | 2024-01-15 |
| 05060462240029 | OrganOx metra | ORGANOX LIMITED | 2023-02-20 |
| 05060462240005 | OrganOx metra | ORGANOX LIMITED | 2022-06-15 |
| 05060462240043 | metra Liver Perfusion Circuit Pack | ORGANOX LIMITED | 2022-06-15 |
| B00949381 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00950491 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00950443 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00948895 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00946653 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00946643 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00944915 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00944905 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00944895 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00944707 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00950770 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00950480 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00950421 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00948883 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00946650 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00946640 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00944843 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00944833 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00944823 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |
| B00944705 | OCS Liver System | TRANSMEDICS, INC. | 2021-12-01 |