Home › Device types › NJK
Valve, Pulmonary
FDA product code NJK · Class 3 · Unknown
14
Registered devices
2,012
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
Zephyr Endobronchial Valve — PULMONX CORPORATIONZephyr Delivery Catheter — PULMONX CORPORATIONSpiration Valve System — Gyrus Acmi, LlcSpiration Valve System — Gyrus Acmi, LlcZephyr Delivery Catheter — PULMONX CORPORATIONSpiration Valve System — Gyrus Acmi, LlcSpiration Valve System — Gyrus Acmi, LlcZephyr Delivery Catheter — PULMONX CORPORATIONSpiration Valve System — Gyrus Acmi, LlcSpiration Valve System — Gyrus Acmi, LlcZephyr Endobronchial Valve — PULMONX CORPORATIONZephyr Delivery Catheter — PULMONX CORPORATIONZephyr Endobronchial Valve — PULMONX CORPORATIONZephyr Endobronchial Valve — PULMONX CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-31 | Pulmonx, Corp. | Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024. |
| 2021-12-23 | Olympus Corporation of the Americas | Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) |
| 2003-09-10 | Cryolife Inc | Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by trans |
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