FDA product code LSX: Controller, Closed-Loop, Blood-Pressure
LSX is the FDA product code for controller, closed-loop, blood-pressure. It is a Class III device, reviewed by the General Hospital panel. Devices under LSX 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 | Controller, Closed-Loop, Blood-Pressure |
| Device class | Class III |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LSX devices
openFDA lists no recalls for product code LSX.
Frequently asked questions
What is FDA product code LSX?
LSX is the FDA product code for controller, closed-loop, blood-pressure. It is a Class III device, reviewed by the General Hospital panel.
What device class is LSX?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LSX
- Run a recall and safety report across every LSX manufacturer
- Watch product code LSX 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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