FDA product code LWT: Occluder, Balloon, Vena-Cava
LWT is the FDA product code for occluder, balloon, vena-cava. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LWT 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 | Occluder, Balloon, Vena-Cava |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LWT devices
openFDA lists no recalls for product code LWT.
Frequently asked questions
What is FDA product code LWT?
LWT is the FDA product code for occluder, balloon, vena-cava. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LWT?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LWT
- Run a recall and safety report across every LWT manufacturer
- Watch product code LWT 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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