# OAZ · One-Way Air-Leak Valve

_ ·  · Class f_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/AN-misc/OAZ

## Overview

- **Product Code:** OAZ
- **Device Name:** One-Way Air-Leak Valve
- **Regulation:** 21 CFR N/A
- **Device Class:** f
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

To restrict air flow to the target section of the lung.  To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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