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
Valve, Pulmonary NJK

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