FDA product code QEJ: Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
QEJ is the FDA product code for flushing solution for short term storage of veins at room temperature during coronary artery bypass graft surgeries. It is a Class II device, regulated under 21 CFR 876.4100 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under QEJ, 1 in the last five years. The average 510(k) review took 27 days (median 27); 27 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A flushing and storage solution for vascular autografts is a device that is used for flushing or short-term storage of vascular grafts. This generic type of device is intended to maintain cell viability and structural integrity of vascular grafts during short-term storage at room temperature during the surgical procedure.
Classification
| Field | Value |
|---|---|
| Device name | Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries |
| Device class | Class II |
| Regulation | 21 CFR 876.4100 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for QEJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 27 |
Compare with all 510(k) review times · Search every QEJ clearance
Top QEJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marizyme | 1 | 2024-05-01 |
Most recent QEJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240925 | Marizyme | DuraGraft Vascular Conduit Solution | 2024-05-01 | 27 |
Recalls for QEJ devices
openFDA lists no recalls for product code QEJ.
Frequently asked questions
What is FDA product code QEJ?
QEJ is the FDA product code for flushing solution for short term storage of veins at room temperature during coronary artery bypass graft surgeries. It is a Class II device, regulated under 21 CFR 876.4100 and reviewed by the Gastroenterology and Urology panel.
What device class is QEJ?
Class II, regulation 21 CFR 876.4100. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEJ?
Across 1 cleared submissions the average was 27 days from receipt to decision (median 27).
Which companies have the most QEJ clearances?
Marizyme (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QEJ
- Run a recall and safety report across every QEJ manufacturer
- Watch product code QEJ 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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