

# NJK · Valve, Pulmonary

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/miscellaneous/NJK

## Overview

- **Product Code:** NJK
- **Device Name:** Valve, Pulmonary
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

To improve lung function in patients with emphysema

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P180007](https://fda.innolitics.com/submissions/AN/miscellaneous/NJK/P180007.md) | Spiration® Valve System | Gyrus Acmi, Inc. | Dec 3, 2018 | APPR |
| [P180002](https://fda.innolitics.com/submissions/AN/miscellaneous/NJK/P180002.md) | Zephyr Endobronchial Valve System | Pulmonx Corporation | Jun 29, 2018 | APPR |

## Top Applicants

- Gyrus Acmi, Inc. — 1 clearance
- Pulmonx Corporation — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/AN/miscellaneous/NJK](https://fda.innolitics.com/submissions/AN/miscellaneous/NJK)

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