Product code
PYX: Temporary non-roller type right heart support blood pump
FDA product code · Class III · Cardiovascular
Key facts
| Product code | PYX |
|---|---|
| Device | Temporary non-roller type right heart support blood pump |
| Device class | Class III |
| Regulation number | 870.4360 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | Providing temporary partial or full right heart circulatory support. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1,000+ 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