FDA product code LXN: Probe, Test, Heart-Valve
LXN is the FDA product code for probe, test, heart-valve. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under LXN, from 2 different applicants. The average 510(k) review took 53 days (median 53).
Classification
| Field | Value |
|---|---|
| Device name | Probe, Test, Heart-Valve |
| Device class | Class I |
| Regulation | 21 CFR 870.4500 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LXN clearance
Top LXN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dhason Brothers, Inc. | 1 | 1989-02-13 |
| Baxter Healthcare Corp | 1 | 1988-06-15 |
Most recent LXN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890165 | Dhason Brothers, Inc. | FORCEPS-ORTHOPEDIC | 1989-02-13 | 35 |
| K881449 | Baxter Healthcare Corp | EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 | 1988-06-15 | 71 |
Recalls for LXN devices
openFDA lists no recalls for product code LXN.
Frequently asked questions
What is FDA product code LXN?
LXN is the FDA product code for probe, test, heart-valve. It is a Class I device, regulated under 21 CFR 870.4500 and reviewed by the Cardiovascular panel.
What device class is LXN?
Class I, regulation 21 CFR 870.4500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LXN?
Across 2 cleared submissions the average was 53 days from receipt to decision (median 53).
Which companies have the most LXN clearances?
Dhason Brothers, Inc. (1); Baxter Healthcare Corp (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LXN
- Run a recall and safety report across every LXN manufacturer
- Watch product code LXN 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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