Is this your brand? Sign in to claim ownership.
Sign in to claim this brandPulmonx Corporation
United States·US-MF-000038432
Last updated May 30, 2026
Information
- Country
- United States
- Address
- 700, Chesapeake Drive, Redwood City, United States
- Website
- pulmonx.com/about-pulmonx/
- —
- —
- [email protected]
- Phone
- +1 650 364 0400
- PRRC Contact
- Rizwan Pervez
- EUDAMED SRN
- US-MF-000038432
- FDA FEI Number
- —
- DUNS Number
- 958582595
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Zephyr Delivery Catheter | EDC-TS-5.5 | FDA UDI | Class III | Active |
| Chartis Console | G3 | FDA UDI | Class II | Active |
| Pulmonx Chartis Tablet Console | CHR-CO-300 | FDA UDI | Class II | Active |
| Zephyr Delivery Catheter | EDC-TS-4.0 | FDA UDI | Class III | Active |
| Zephyr Endobronchial Valve | EBV-TS-5.5-LP | FDA UDI | Class III | Active |
| Lung Image Analysis | LIA-01-001 | FDA UDI | Class II | Active |
| Chartis Catheter | G3 | FDA UDI | Class II | Active |
| Chartis Catheter | G3 | FDA UDI | Class II | Active |
| Zephyr Endobronchial Valve | EBV-TS-4.0-LP | FDA UDI | Class III | Active |
| Zephyr Endobronchial Valve | EBV-TS-4.0 | FDA UDI | Class III | Active |
| Zephyr Delivery Catheter | EDC-TS-4.0-J | FDA UDI | Class III | Active |
| Pulmonx Chartis Tablet Console | CHR-CO-300 | FDA UDI | Class II | Active |
| Zephyr Delivery Catheter | EDC-TS-5.5-DM | FDA UDI | Class III | Active |
| Zephyr Endobronchial Valve | EBV-TS-5.5 | FDA UDI | Class III | Active |
| Chartis Precision Catheter | G4 | FDA UDI | Class II | Active |
| Pulmonx Chartis Tablet Console | K180011 | FDA 510(k) | Class II | Active |
| Lung Image Analysis | K212494 | FDA 510(k) | Class II | Active |
| Chartis Precision Catheter | K222340 | FDA 510(k) | Class II | Active |
| Chartis Precision Catheter | K253096 | FDA 510(k) | Class II | Active |
| The Visualized Endotracheal Tube System Or Vett System | K973191 | FDA 510(k) | Class II | Active |
| Chartis Console | K083199 | FDA 510(k) | Class II | Active |
| Chartis Catheter Model Chr-Ca-12.0 | K111522 | FDA 510(k) | Class II | Active |
| Chartis Console | K111764 | FDA 510(k) | Class II | Active |
| Chartis Pulmonary Assessment System Catheter | CHR-CA-12.0 | EUDAMED | Class IIa | Active |
| Chartis Pulmonary Assessment Catheter XL | CHR-CA-12.0-XL | EUDAMED | Class IIa | Active |
| Zephyr Endobronchial Valve (EBV) System | P180002 | FDA PMA | Class III | Active |
Related Companies
Authorised Representatives
- Pulmonx GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 31, 2023 | Z-0235-2024 | — | open, classified | 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. |