FDA product code QEK: Angiographic Coronary Vascular Physiologic Simulation Software
QEK is the FDA product code for angiographic coronary vascular physiologic simulation software. It is a Class II device, regulated under 21 CFR 870.1415 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under QEK. The average 510(k) review took 114 days (median 114).
Definition
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Classification
| Field | Value |
|---|---|
| Device name | Angiographic Coronary Vascular Physiologic Simulation Software |
| Device class | Class II |
| Regulation | 21 CFR 870.1415 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QEK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 133 |
| 2019 | 1 | 94 |
Compare with all 510(k) review times · Search every QEK clearance
Top QEK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cathworks, Ltd. | 2 | 2019-12-09 |
Most recent QEK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192442 | Cathworks, Ltd. | FFRangio | 2019-12-09 | 94 |
| K182149 | Cathworks, Ltd. | FFRangio System | 2018-12-19 | 133 |
Recalls for QEK devices
openFDA lists no recalls for product code QEK.
Frequently asked questions
What is FDA product code QEK?
QEK is the FDA product code for angiographic coronary vascular physiologic simulation software. It is a Class II device, regulated under 21 CFR 870.1415 and reviewed by the Cardiovascular panel.
What device class is QEK?
Class II, regulation 21 CFR 870.1415. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEK?
Across 2 cleared submissions the average was 114 days from receipt to decision (median 114).
Which companies have the most QEK clearances?
Cathworks, Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QEK
- Run a recall and safety report across every QEK manufacturer
- Watch product code QEK 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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