FDA product code PKK: Stent Delivery System
PKK is the FDA product code for stent delivery system. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under PKK reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
For coarctation of the aorta
Classification
| Field | Value |
|---|---|
| Device name | Stent Delivery System |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for PKK devices
openFDA lists no recalls for product code PKK.
Frequently asked questions
What is FDA product code PKK?
PKK is the FDA product code for stent delivery system. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is PKK?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code PKK
- Run a recall and safety report across every PKK manufacturer
- Watch product code PKK 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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