FDA Registration
Active
🇺🇸 United States
Lotus Central Venous Catheter
Reg #: 3035111606
·
FEI: 3035111606
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- GAMAMED VASCULAR SYSTEMS INC.
- Registration Number
- 3035111606
- FEI Number
- 3035111606
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1607 Capitol Ave Suite 327
- City
- Cheyenne
- State
- WY
- ZIP
- 82001
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070451
Owner / Operator
- Firm Name
- Gamamed Vascular Systems Inc.
- Operator Number
- 10092344
- Address
- 1607 Capitol Ave Suite 327
- City
- Cheyenne
- State
- WY
- Postal Code
- 82001
- Country
- US
- Correspondent
- Lorena Arrieche
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2024-12-29 |
Proprietary Names
Lotus Central Venous Catheter
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device