OJE

Right Ventricular Bypass (Assist) Device

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OJE
Classification and pathway per current FDA publications. Data from openFDA (CC0).