FDA product code MCX: Catheter, Coronary, Atherectomy
MCX is the FDA product code for catheter, coronary, atherectomy. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MCX reach the market by PMA; FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code. FDA has posted 14 recalls for MCX devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Coronary, Atherectomy |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MCX devices
14 product recalls in 12 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2022-03-08.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code MCX?
MCX is the FDA product code for catheter, coronary, atherectomy. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MCX?
Class III. Typical premarket route: PMA.
Have MCX devices been recalled?
Yes: 14 product recalls across 12 recall events; the most recent began 2022-03-08.
Next steps
- Run an FDA pathway report with predicate devices for product code MCX
- Run a recall and safety report across every MCX manufacturer
- Watch product code MCX 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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