Product code
QQK: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
FDA product code · Class III · Gastroenterology/Urology
Key facts
| Product code | QQK |
|---|---|
| Device | Normothermic machine perfusion system for the preservation of donor livers prior to transplantation |
| Device class | Class III |
| Review panel | Gastroenterology/Urology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | The device is intended for machine preservation of donor livers prior to transplantation. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database