FDA Registration
Active
🇺🇸 United States
Broncus Medical Inc
Reg #: 3007867778
·
FEI: 3007867778
·
Expires 2026
Products
3
Proprietary Names
15
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Broncus Medical Inc
- Registration Number
- 3007867778
- FEI Number
- 3007867778
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 125 Nicholson Ln
- City
- San Jose
- State
- CA
- ZIP
- 95134
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093423
Owner / Operator
- Firm Name
- Broncus Medical, Inc.
- Operator Number
- 10030260
- Address
- 125 Nicholson Lane
- City
- San Jose
- State
- CA
- Postal Code
- 95134
- Country
- US
- Correspondent
- Antoinette M Clay
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2009-12-28 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2009-12-28 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2019-02-27 |
Proprietary Names
LungPoint Planning
LungPoint Procedure Planning
Archimedes System
FleXNeedle 18ga
FleXNeedle
FleXNeedle 21ga
Yield Tissue Sampler
BioStar® Transbronchial Aspiration Needle
BroncTru Transbronchial Access Tool
EMPOWER RF Catheter
LungPoint VBN
EasyPath RF Introducer Sheath
Archimedes Dilation Balloon
Archimedes Access Kit
Archimedes Sheath
Establishment Types
Manufacture Medical Device