FDA product code PCX: Artificial Chordae Tendinae Delivery System
PCX is the FDA product code for artificial chordae tendinae delivery system. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under PCX reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Deploys ePTFE suture, labeled for use as artificial chordae tendinae, while the heart is beating as an alternative to the conventional surgical approach for this type of mitral valve repair.
Classification
| Field | Value |
|---|---|
| Device name | Artificial Chordae Tendinae Delivery System |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for PCX devices
openFDA lists no recalls for product code PCX.
Frequently asked questions
What is FDA product code PCX?
PCX is the FDA product code for artificial chordae tendinae delivery system. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is PCX?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PCX
- Run a recall and safety report across every PCX manufacturer
- Watch product code PCX 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.