Zephyr Endobronchial Valve (EBV) System
FDA premarket approval P180002/S026 · decided 2024-03-01
Approval details
- PMA number
- P180002
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zephyr Endobronchial Valve (EBV) System
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2024-02-01
- Decision date
- 2024-03-01
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Manufacturing change allowing option to perform two sterilization cycles on the Zephyr Endobronchial Delivery Catheters.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Chartis Precision Catheter (K253096) | Pulmonx Corporation | 2026-02-13 |
| Chartis Precision Catheter (K222340) | Pulmonx Corporation | 2022-12-01 |
| Lung Image Analysis (K212494) | Pulmonx Corporation | 2021-09-02 |
| Pulmonx Chartis Tablet Console (K180011) | Pulmonx Corporation | 2018-07-13 |