FDA product code PXB: Percutaneous Introducer Kit
PXB is the FDA product code for percutaneous introducer kit. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel. Devices under PXB 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 | Percutaneous Introducer Kit |
| Device class | Class II |
| Regulation | 21 CFR 880.5570 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for PXB devices
openFDA lists no recalls for product code PXB.
Frequently asked questions
What is FDA product code PXB?
PXB is the FDA product code for percutaneous introducer kit. It is a Class II device, regulated under 21 CFR 880.5570 and reviewed by the General Hospital panel.
What device class is PXB?
Class II, regulation 21 CFR 880.5570. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PXB
- Run a recall and safety report across every PXB manufacturer
- Watch product code PXB 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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