FDA product code PAX: Surgical Kit
PAX is the FDA product code for surgical kit. It is a HDE device, reviewed by the Neurology panel. Devices under PAX reach the market by Unclassified; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for PAX devices.
Definition
For creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
Classification
| Field | Value |
|---|---|
| Device name | Surgical Kit |
| Device class | HDE |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for PAX devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-27.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code PAX?
PAX is the FDA product code for surgical kit. It is a HDE device, reviewed by the Neurology panel.
What device class is PAX?
HDE. Typical premarket route: Unclassified.
Have PAX devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-03-27.
Next steps
- Run an FDA pathway report with predicate devices for product code PAX
- Run a recall and safety report across every PAX manufacturer
- Watch product code PAX 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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