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
System, Ablation, Microwave And Accessories NEY

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