OJE — Right Ventricular Bypass (Assist) Device Class f
FDA product code OJE covers "Right Ventricular Bypass (Assist) Device", a Class f medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OJE
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- No
Definition
To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.