FDA product code PPO: Multi-Lumen Hemodialysis Catheterization Kit
PPO is the FDA product code for multi-lumen hemodialysis catheterization kit. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. Devices under PPO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Multi-Lumen Hemodialysis Catheterization Kit |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Recalls for PPO devices
openFDA lists no recalls for product code PPO.
Frequently asked questions
What is FDA product code PPO?
PPO is the FDA product code for multi-lumen hemodialysis catheterization kit. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is PPO?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PPO
- Run a recall and safety report across every PPO manufacturer
- Watch product code PPO 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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