FDA product code QEY: Mechanical Thrombolysis Catheter
QEY is the FDA product code for mechanical thrombolysis catheter. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel. FDA has cleared 71 510(k) submissions under QEY, 6 in the last five years, from 18 different applicants. The average 510(k) review took 79 days (median 68); 149 days on average over the last three years. FDA has posted 4 recalls for QEY devices, 4 initiated in the last five years.
Definition
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
Classification
| Field | Value |
|---|---|
| Device name | Mechanical Thrombolysis Catheter |
| 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 QEY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 117 |
| 2018 | 1 | 91 |
| 2019 | 5 | 81 |
| 2020 | 3 | 141 |
| 2021 | 3 | 113 |
| 2022 | 1 | 26 |
| 2023 | 2 | 152 |
| 2024 | 1 | 151 |
| 2026 | 2 | 147 |
Compare with all 510(k) review times · Search every QEY clearance
Top QEY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ekos Corp. | 17 | 2008-06-26 |
| Bacchus Vascular, Inc. | 7 | 2008-10-17 |
| Thrombolex, Inc. | 6 | 2023-07-03 |
| AngioDynamics, Inc. | 6 | 2020-09-15 |
| Btg International, Inc. | 5 | 2019-08-23 |
13 more applicants have QEY clearances. See the full list in Caduvo.
Most recent QEY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260149 | Liquet Medical, Inc. | Versus Catheter (VS110-9NB) | 2026-02-17 | 28 |
| K251318 | Argon Medical Devices, Inc. | VariFuse Adjustable Infusion Catheter | 2026-01-20 | 266 |
| K241851 | Liquet Medical, Inc. | Versus Catheter (VS110-8B) | 2024-11-25 | 151 |
| K231653 | Thrombolex, Inc. | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter | 2023-07-03 | 27 |
| K222095 | Thrombolex, Inc. | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | 2023-04-20 | 276 |
Recalls for QEY devices
4 product recalls in 3 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-11-06.
| Year | Recalls |
|---|---|
| 2022 | 3 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code QEY?
QEY is the FDA product code for mechanical thrombolysis catheter. It is a Class II device, regulated under 21 CFR 870.5150 and reviewed by the Cardiovascular panel.
What device class is QEY?
Class II, regulation 21 CFR 870.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEY?
Across 71 cleared submissions the average was 79 days from receipt to decision (median 68).
Which companies have the most QEY clearances?
Ekos Corp. (17); Bacchus Vascular, Inc. (7); Thrombolex, Inc. (6); AngioDynamics, Inc. (6); Btg International, Inc. (5).
Have QEY devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2023-11-06.
Next steps
- Run an FDA pathway report with predicate devices for product code QEY
- Run a recall and safety report across every QEY manufacturer
- Watch product code QEY 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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