OJEHumanitarian device exemption

Right Ventricular Bypass (Assist) Device

Unknown

OJE is the FDA product code for Right Ventricular Bypass (Assist) Device. FDA's definition for this code reads: "To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: OJE
Device name: Right Ventricular Bypass (Assist) Device
FDA definition: To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
Device class: Humanitarian device exemption
Review panel: Unknown
Submission type: FDA code 6
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code OJE

FDA records hold no clearances under product code OJE.

Recent recalls

Product code OJE

FDA records show no recalls under product code OJE.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)