FDA Registration
Active
🇺🇸 United States
Footswitch- RFASW; & Remote Temperature Probe- RTP20
Reg #: 3008361498
·
FEI: 3008361498
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Covidien
- Registration Number
- 3008361498
- FEI Number
- 3008361498
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2800 Airwest Blvd, Suite 160
- City
- Plainfield
- State
- IN
- ZIP
- 46168
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133821
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2014-05-16 |
Proprietary Names
Footswitch- RFASW; & Remote Temperature Probe- RTP20
Emprint Microwave Ablation System- CAMSYS
Includes Generator- CAGEN1; Percutaneous Antenna- CA15L1, CA20L1, CA30L1; Pump- CAPUMP1; Reusable Cable- CA190RC1
Establishment Types
Manufacture Medical Device