FDA product code LWQ: Heart-Valve, Mechanical
LWQ is the FDA product code for heart-valve, mechanical. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LWQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 12 PMA applications cite this product code. FDA has posted 5 recalls for LWQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Heart-Valve, Mechanical |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for LWQ devices
5 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-02-01.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LWQ?
LWQ is the FDA product code for heart-valve, mechanical. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LWQ?
Class III. Typical premarket route: PMA.
Have LWQ devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2026-02-01.
Next steps
- Run an FDA pathway report with predicate devices for product code LWQ
- Run a recall and safety report across every LWQ manufacturer
- Watch product code LWQ 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times