FDA product code LPC: Device, Angioplasty, Laser, Coronary
LPC is the FDA product code for device, angioplasty, laser, coronary. It is a Class III device, reviewed by the Cardiovascular panel. Devices under LPC reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 4 recalls for LPC devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Angioplasty, Laser, Coronary |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LPC devices
4 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-10-14.
| Year | Recalls |
|---|---|
| 2022 | 2 |
Frequently asked questions
What is FDA product code LPC?
LPC is the FDA product code for device, angioplasty, laser, coronary. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is LPC?
Class III. Typical premarket route: PMA.
Have LPC devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2022-10-14.
Next steps
- Run an FDA pathway report with predicate devices for product code LPC
- Run a recall and safety report across every LPC manufacturer
- Watch product code LPC 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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