Medical device licence · 104190 · Class 3
C2 CRYOBALLOON ABLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 21, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104190
- Licence holder
- Pentax Medical, A Division Of Pentax Of America, IncRedwood City, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 21, 2020
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- C2 CRYOBALLOON CARTRIDGE
- C2 CRYOBALLOON CONTOUR CATHETER
- C2 CRYOBALLOON CONTROLLER
- C2 CRYOBALLOON FOOT PEDAL
- C2 CRYOBALLOON PEAR 180º CATHETER (LOW DOSE CONFIGURATION)
- C2 CRYOBALLOON PEAR CATHETER
- C2 CRYOBALLOON STANDARD 180º CATHETER (LOW DOSE CONFIGURATION)
- C2 CRYOBALLOON STANDARD CATHETER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.