FDA product code LXW: Column, Adsorption, Low Density, Lipoprotein
LXW is the FDA product code for column, adsorption, low density, lipoprotein. It is a Class III device, reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under LXW. The average 510(k) review took 187 days (median 187).
Classification
| Field | Value |
|---|---|
| Device name | Column, Adsorption, Low Density, Lipoprotein |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Compare with all 510(k) review times · Search every LXW clearance
Top LXW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baltimore Therapeutic Equipment Co. | 1 | 1990-04-10 |
Most recent LXW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895881 | Baltimore Therapeutic Equipment Co. | MOTIONSPECT | 1990-04-10 | 187 |
Recalls for LXW devices
openFDA lists no recalls for product code LXW.
Frequently asked questions
What is FDA product code LXW?
LXW is the FDA product code for column, adsorption, low density, lipoprotein. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is LXW?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code LXW?
Across 1 cleared submissions the average was 187 days from receipt to decision (median 187).
Which companies have the most LXW clearances?
Baltimore Therapeutic Equipment Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LXW
- Run a recall and safety report across every LXW manufacturer
- Watch product code LXW 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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