Medical device licence · 108529 · Class 4
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 10, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 108529
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- November 10, 2022
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HAWKONE CATHETER
- HAWKONE CUTTER DRIVER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.