Product code
OJE: Right ventricular bypass (assist) device
FDA product code · HDE · Cardiovascular
Key facts
| Product code | OJE |
|---|---|
| Device | Right ventricular bypass (assist) device |
| Device class | HDE |
| Review panel | Cardiovascular |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None 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