FDA Registration
Active
🇺🇸 United States
COBRA Fusion Magnetic Retriever
Reg #: 3011706110
·
FEI: 3011706110
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ATRICURE, INC.
- Registration Number
- 3011706110
- FEI Number
- 3011706110
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7555 Innovation Way
- City
- Mason
- State
- OH
- ZIP
- 45040
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113475
Owner / Operator
- Firm Name
- ATRICURE, INC.
- Operator Number
- 9045049
- Address
- 7555 Innovation Way, --
- City
- Mason
- State
- OH
- Postal Code
- 45040
- Country
- US
- Correspondent
- John S Ehlert
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | Class 2 | General, Plastic Surgery | No | 2015-01-02 |
Proprietary Names
COBRA Fusion Magnetic Retriever
COBRA Fusion 150 Ablation System Kit
COBRA Fusion 50 Ablation System
COBRA Fusion 150 Ablation System
COBRA Fusion Pacing Recorder Adapter Cable
COBRA Fusion 50 Ablation System Kit
COBRA Fusion Magnetic Retriever System Kit
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device