FDA product code QXZ: Adjunctive Epicardial Vascular Physiologic Status Indicator
QXZ is the FDA product code for adjunctive epicardial vascular physiologic status indicator. It is a Class II device, regulated under 21 CFR 870.2200 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QXZ, 1 in the last five years. The average 510(k) review took 123 days (median 123).
Definition
The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy.
Classification
| Field | Value |
|---|---|
| Device name | Adjunctive Epicardial Vascular Physiologic Status Indicator |
| Device class | Class II |
| Regulation | 21 CFR 870.2200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QXZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 123 |
Compare with all 510(k) review times · Search every QXZ clearance
Top QXZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cleerly, Inc. | 1 | 2023-09-08 |
Most recent QXZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231335 | Cleerly, Inc. | Cleerly ISCHEMIA | 2023-09-08 | 123 |
Recalls for QXZ devices
openFDA lists no recalls for product code QXZ.
Frequently asked questions
What is FDA product code QXZ?
QXZ is the FDA product code for adjunctive epicardial vascular physiologic status indicator. It is a Class II device, regulated under 21 CFR 870.2200 and reviewed by the Cardiovascular panel.
What device class is QXZ?
Class II, regulation 21 CFR 870.2200. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXZ?
Across 1 cleared submissions the average was 123 days from receipt to decision (median 123).
Which companies have the most QXZ clearances?
Cleerly, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QXZ
- Run a recall and safety report across every QXZ manufacturer
- Watch product code QXZ 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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