FDA Registration
Active
🇺🇸 United States
PULMONX, Corp.
Reg #: 3007797756
·
FEI: 3007797756
·
Expires 2026
Products
5
Proprietary Names
13
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- PULMONX, Corp.
- Registration Number
- 3007797756
- FEI Number
- 3007797756
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 700 Chesapeake Drive
- City
- Redwood City
- State
- CA
- ZIP
- 94063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212494
- PMA Number
- P180002
Owner / Operator
- Firm Name
- Pulmonx, Corp.
- Operator Number
- 10029906
- Address
- 700 Chesapeake Drive
- City
- Redwood City
- State
- CA
- Postal Code
- 94063
- Country
- US
- Correspondent
- Rizwan Pervez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2022-09-01 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2018-07-17 |
| Valve, Pulmonary | NJK | Class 3 | Unknown | No | 2018-07-11 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | Class 2 | Anesthesiology | No | 2013-01-02 |
| Lung Tissue Sealant For Lung Volume Reduction | POI | Class N | Unknown | No | 2016-07-18 |
Proprietary Names
Lung Image Analysis
Chartis Tablet Console
Zephyr 4-LP Endobronchial Valve
Zephyr 5.5 Endobronchial Delivery Catheter
Zephyr 5.5 Endobronchial Valve
Zephyr 4 Endobronchial Valve
Zephyr 4 Endobronchial Delivery Catheter
Zephyr 4-J Endobronchial Delivery Catheter
Zephyr 5.5-LP Endobronchial Valve
Zephyr 5.5 Dual Mark Endobronchial Delivery Catheter
Chartis Console
Chartis Catheter
AeriSeal System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Device in the United States for Export Only