OJE
- Product code
- OJE
- Device name
- Right Ventricular Bypass (Assist) Device
- Device class
- Class F
- Medical specialty
- Unknown
- Marketing pathway
- HDE - Humanitarian Device Exemption
FDA classification definition
To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
Official FDA classification page: OJE
Classification and pathway per current FDA publications. Data from openFDA (CC0).