FDA Registration
Active
🇺🇸 United States
Zephyr 5.5 Endobronchial Valve
Reg #: 3007797756
·
FEI: 3007797756
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PULMONX, Corp.
- Registration Number
- 3007797756
- FEI Number
- 3007797756
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 700 Chesapeake Drive
- City
- Redwood City
- State
- CA
- ZIP
- 94063
- Country
- US
Regulatory Submissions
- 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 |
|---|---|---|---|---|---|
| Valve, Pulmonary | NJK | Class 3 | Unknown | No | 2018-07-11 |
Proprietary Names
Zephyr 5.5 Endobronchial Valve
Zephyr 5.5 Endobronchial Delivery Catheter
Zephyr 4-LP Endobronchial Valve
Zephyr 5.5 Dual Mark Endobronchial Delivery Catheter
Zephyr 4 Endobronchial Valve
Zephyr 4 Endobronchial Delivery Catheter
Zephyr 4-J Endobronchial Delivery Catheter
Zephyr 5.5-LP Endobronchial Valve
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device