FDA product code LWX: Device. Laser Peripheral Angioplasty
LWX is the FDA product code for device. laser peripheral angioplasty. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LWX reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Device. Laser Peripheral Angioplasty |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LWX devices
openFDA lists no recalls for product code LWX.
Frequently asked questions
What is FDA product code LWX?
LWX is the FDA product code for device. laser peripheral angioplasty. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LWX?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LWX
- Run a recall and safety report across every LWX manufacturer
- Watch product code LWX 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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