Product code NJK
- Device name
- Valve, Pulmonary
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- AN
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To improve lung function in patients with emphysema
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P180007S015 | Spiration Valve System (SVS) | Gyrus Acmi, Inc. | 2026-05-07 |
| P180002S030 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2026-03-17 |
| P180002S029 | Zephyr Endobronchial Valve System | Pulmonx Corporation | 2024-12-04 |
| P180002S028 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2024-08-23 |
| P180007S013 | Spiration® Valve System | Gyrus Acmi, Inc. | 2024-08-16 |
| P180007S012 | Spiration Valve System Deployment Catheter and Loader | Gyrus Acmi, Inc. | 2024-06-27 |
| P180002S027 | Zephyr Endobronchial Valve System | Pulmonx Corporation | 2024-05-13 |
| P180002S025 | Zephyr Endobronchial Valve System | Pulmonx Corporation | 2024-03-22 |
| P180002S026 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2024-03-01 |
| P180007S011 | Spiration Valve System | Gyrus Acmi, Inc. | 2023-09-22 |
| P180002S024 | modified 4.0-LP funnel component | Pulmonx Corporation | 2023-09-05 |
| P180002S022 | Zephyr Valve Reigstry (ZEVR) | Pulmonx Corporation | 2023-03-25 |
| P180007S009 | SVS Deployment Catheter and Loader | Gyrus Acmi, Inc. | 2022-05-12 |
| P180002S020 | Zephyr Valve Registry (ZEVR) | Pulmonx Corporation | 2022-03-09 |
| P180007S008 | Spiration Valve System | Gyrus Acmi, Inc. | 2021-09-01 |
| P180002S019 | Zephyr Endobronchial Valve (Zephyr Valve) | Pulmonx Corporation | 2021-08-13 |
| P180007S007 | Spiration® Valve System (SVS) | Gyrus Acmi, Inc. | 2020-12-23 |
| P180007S005 | Spiration® Valve System | Gyrus Acmi, Inc. | 2020-12-15 |
| P180002S017 | Zephyr Endobronchial Valve System | Pulmonx Corporation | 2020-11-19 |
| P180002S016 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2020-10-30 |
| P180002S015 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2020-10-06 |
| P180002S011 | Zephyr Endobronchial Valve System | Pulmonx Corporation | 2019-12-23 |
| P180002S014 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2019-12-06 |
| P180002S013 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2019-11-21 |
| P180002S012 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2019-11-21 |
| P180002S010 | Zephyr 5.5 EBV Circle Flange Valve | Pulmonx Corporation | 2019-11-13 |
| P180002S009 | Zephyr Valve Registry (ZEVR) | Pulmonx Corporation | 2019-10-02 |
| P180002S007 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2019-08-01 |
| P180002S005 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2019-07-30 |
| P180002S006 | Zephyr Endobronchial Valve (EBV) System | Pulmonx Corporation | 2019-07-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811907030423 | Zephyr Endobronchial Valve | PULMONX CORPORATION | 2019-08-23 |
| 00811907031222 | Zephyr Delivery Catheter | PULMONX CORPORATION | 2019-08-23 |
| 00896506002279 | Spiration Valve System | Gyrus Acmi, Llc | 2019-03-29 |
| 00896506002286 | Spiration Valve System | Gyrus Acmi, Llc | 2019-03-29 |
| 00896506002293 | Spiration Valve System | Gyrus Acmi, Llc | 2019-03-29 |
| 00896506002309 | Spiration Valve System | Gyrus Acmi, Llc | 2019-03-29 |
| 00896506002316 | Spiration Valve System | Gyrus Acmi, Llc | 2019-03-29 |
| 00896506002323 | Spiration Valve System | Gyrus Acmi, Llc | 2019-03-29 |
| 00811907030126 | Zephyr Endobronchial Valve | PULMONX CORPORATION | 2018-07-20 |
| 00811907030225 | Zephyr Endobronchial Valve | PULMONX CORPORATION | 2018-07-20 |
| 00811907030324 | Zephyr Endobronchial Valve | PULMONX CORPORATION | 2018-07-20 |
| 00811907030522 | Zephyr Delivery Catheter | PULMONX CORPORATION | 2018-07-20 |
| 00811907030621 | Zephyr Delivery Catheter | PULMONX CORPORATION | 2018-07-20 |
| 00811907030720 | Zephyr Delivery Catheter | PULMONX CORPORATION | 2018-07-20 |