FDA product code PKI: Fully Subcutaneous Implanted Hemodialysis Catheter
PKI is the FDA product code for fully subcutaneous implanted hemodialysis catheter. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. Devices under PKI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Provides access to the blood for hemodialysis or other chronic uses.
Classification
| Field | Value |
|---|---|
| Device name | Fully Subcutaneous Implanted Hemodialysis Catheter |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for PKI devices
openFDA lists no recalls for product code PKI.
Frequently asked questions
What is FDA product code PKI?
PKI is the FDA product code for fully subcutaneous implanted hemodialysis catheter. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is PKI?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PKI
- Run a recall and safety report across every PKI manufacturer
- Watch product code PKI 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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