FDA product code QEX: Coronary Mechanical Thrombectomy With Aspiration
QEX is the FDA product code for coronary mechanical thrombectomy with aspiration. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel. FDA has cleared 3 510(k) submissions under QEX, 1 in the last five years, from 3 different applicants. The average 510(k) review took 96 days (median 80); 55 days on average over the last three years.
Definition
To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.
Classification
| Field | Value |
|---|---|
| Device name | Coronary Mechanical Thrombectomy With Aspiration |
| Device class | Class II |
| Regulation | 21 CFR 870.5150 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QEX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 116 |
| 2025 | 1 | 55 |
Compare with all 510(k) review times · Search every QEX clearance
Top QEX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vesalio, Inc. | 1 | 2025-11-24 |
| Capture Vascular, Inc. | 1 | 2017-08-10 |
| Penumbra, Inc. | 1 | 2017-05-24 |
Most recent QEX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253407 | Vesalio, Inc. | NeVa PV Thrombectomy Device | 2025-11-24 | 55 |
| K171493 | Capture Vascular, Inc. | MegaVac Mechanical Thrombectomy System | 2017-08-10 | 80 |
| K163618 | Penumbra, Inc. | INDIGO Aspiration System | 2017-05-24 | 153 |
Recalls for QEX devices
openFDA lists no recalls for product code QEX.
Frequently asked questions
What is FDA product code QEX?
QEX is the FDA product code for coronary mechanical thrombectomy with aspiration. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel.
What device class is QEX?
Class II, regulation 21 CFR 870.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEX?
Across 3 cleared submissions the average was 96 days from receipt to decision (median 80).
Which companies have the most QEX clearances?
Vesalio, Inc. (1); Capture Vascular, Inc. (1); Penumbra, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QEX
- Run a recall and safety report across every QEX manufacturer
- Watch product code QEX 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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