Medical device licence · 89917 · Class 2
AFFINITY AF100 ARTERIAL FILTER
Yes: licensed in Canada
Licence status Issued (active); first licensed October 19, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89917
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- October 19, 2012
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AFFINITY AF100 ARTERIAL BLOOD FILTER WITH BALANCE BIOSURFACE
- AFFINITY AF100 ARTERIAL FILTER WITH CORTIVA BIOACTIVE SURFACE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.