FDA product code LWR: Heart-Valve, Non-Allograft Tissue
LWR is the FDA product code for heart-valve, non-allograft tissue. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LWR reach the market by PMA; FDA lists no cleared 510(k)s for it. 13 PMA applications cite this product code. FDA has posted 7 recalls for LWR devices.
Classification
| Field | Value |
|---|---|
| Device name | Heart-Valve, Non-Allograft Tissue |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LWR devices
7 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-07-29.
| Year | Recalls |
|---|---|
| 2020 | 5 |
Frequently asked questions
What is FDA product code LWR?
LWR is the FDA product code for heart-valve, non-allograft tissue. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LWR?
Class III. Typical premarket route: PMA.
Have LWR devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2020-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code LWR
- Run a recall and safety report across every LWR manufacturer
- Watch product code LWR 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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