Zephyr 5.5 EBV Circle Flange Valve
FDA premarket approval P180002/S010 · decided 2019-11-13
Approval details
- PMA number
- P180002
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zephyr 5.5 EBV Circle Flange Valve
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2019-08-19
- Decision date
- 2019-11-13
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for the Zephyr 5.5 EBV Circle Flange Valve.
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| Chartis Precision Catheter (K253096) | Pulmonx Corporation | 2026-02-13 |
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| Lung Image Analysis (K212494) | Pulmonx Corporation | 2021-09-02 |
| Pulmonx Chartis Tablet Console (K180011) | Pulmonx Corporation | 2018-07-13 |