FDA product code QEZ: Aspiration Thrombectomy Catheter
QEZ is the FDA product code for aspiration thrombectomy catheter. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel. FDA has cleared 95 510(k) submissions under QEZ, 15 in the last five years, from 34 different applicants. The average 510(k) review took 108 days (median 90); 93 days on average over the last three years.
Definition
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Classification
| Field | Value |
|---|---|
| Device name | Aspiration Thrombectomy Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.5150 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| GMP exempt | Yes |
510(k) clearances per year for QEZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 92 |
| 2018 | 1 | 25 |
| 2019 | 3 | 91 |
| 2020 | 3 | 102 |
| 2021 | 3 | 64 |
| 2022 | 2 | 128 |
| 2023 | 1 | 126 |
| 2024 | 1 | 52 |
| 2025 | 5 | 114 |
| 2026 | 6 | 113 |
Compare with all 510(k) review times · Search every QEZ clearance
Top QEZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Possis Medical, Inc. | 19 | 2009-06-22 |
| Vascular Solutions, Inc. | 13 | 2018-09-11 |
| Walk Vascular, LLC | 9 | 2022-02-01 |
| AngioDynamics, Inc. | 4 | 2025-11-24 |
| Inquis Medical | 3 | 2026-07-27 |
29 more applicants have QEZ clearances. See the full list in Caduvo.
Most recent QEZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254035 | MicroVention, Inc., d/b/a Terumo Neuro | Mayumi Thrombectomy System | 2026-09-03 | 261 |
| K261105 | Inquis Medical | Powered Aventus Thrombectomy System | 2026-07-27 | 115 |
| K262030 | Inquis Medical | Aventus Thrombectomy System | 2026-07-15 | 28 |
| K253589 | Medtronic Interventional Vascular, Inc. | Liberant RX Aspiration Catheter | 2026-04-23 | 157 |
| K254208 | Expanse Medical, Inc. | FLOWRUNNER Aspiration System | 2026-03-20 | 81 |
Recalls for QEZ devices
openFDA lists no recalls for product code QEZ.
Frequently asked questions
What is FDA product code QEZ?
QEZ is the FDA product code for aspiration thrombectomy catheter. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel.
What device class is QEZ?
Class II, regulation 21 CFR 870.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEZ?
Across 95 cleared submissions the average was 108 days from receipt to decision (median 90).
Which companies have the most QEZ clearances?
Possis Medical, Inc. (19); Vascular Solutions, Inc. (13); Walk Vascular, LLC (9); AngioDynamics, Inc. (4); Inquis Medical (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QEZ
- Run a recall and safety report across every QEZ manufacturer
- Watch product code QEZ 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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