Product code OJE
- Device name
- Right Ventricular Bypass (Assist) Device
- Medical specialty
- Unknown
- Device class
- f
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
- Source
- FDA openFDA device classification dataset