FDA product code OJE: Right Ventricular Bypass (Assist) Device
OJE is the FDA product code for right ventricular bypass (assist) device. It is a HDE device, reviewed by the Cardiovascular panel. Devices under OJE reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
Classification
| Field | Value |
|---|---|
| Device name | Right Ventricular Bypass (Assist) Device |
| Device class | HDE |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for OJE devices
openFDA lists no recalls for product code OJE.
Frequently asked questions
What is FDA product code OJE?
OJE is the FDA product code for right ventricular bypass (assist) device. It is a HDE device, reviewed by the Cardiovascular panel.
What device class is OJE?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OJE
- Run a recall and safety report across every OJE manufacturer
- Watch product code OJE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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