FDA product code QXU: Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
QXU is the FDA product code for esophageal protection device for use in percutaneous cardiac catheter ablation procedures, mechanical deviation. It is a Class II device, regulated under 21 CFR 870.5710 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under QXU, 1 in the last five years. The average 510(k) review took 31 days (median 31); 31 days on average over the last three years. 1 De Novo request was granted under it.
Definition
This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy
Classification
| Field | Value |
|---|---|
| Device name | Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation |
| Device class | Class II |
| Regulation | 21 CFR 870.5710 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for QXU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 31 |
Compare with all 510(k) review times · Search every QXU clearance
Top QXU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| S4 Medical Corp. | 1 | 2024-11-09 |
Most recent QXU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243233 | S4 Medical Corp. | esolution® Esophageal Retractor | 2024-11-09 | 31 |
Recalls for QXU devices
openFDA lists no recalls for product code QXU.
Frequently asked questions
What is FDA product code QXU?
QXU is the FDA product code for esophageal protection device for use in percutaneous cardiac catheter ablation procedures, mechanical deviation. It is a Class II device, regulated under 21 CFR 870.5710 and reviewed by the Cardiovascular panel.
What device class is QXU?
Class II, regulation 21 CFR 870.5710. Typical premarket route: 510(k).
How long does a 510(k) take for product code QXU?
Across 1 cleared submissions the average was 31 days from receipt to decision (median 31).
Which companies have the most QXU clearances?
S4 Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QXU
- Run a recall and safety report across every QXU manufacturer
- Watch product code QXU 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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