# PAX · Surgical Kit

_ ·  · Class f_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/NE-misc/PAX

## Overview

- **Product Code:** PAX
- **Device Name:** Surgical Kit
- **Regulation:** 21 CFR N/A
- **Device Class:** f
- **Review Panel:** [](/submissions/)

## Identification

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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/NE/NE-misc/PAX](https://fda.innolitics.com/submissions/NE/NE-misc/PAX)

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