Medical device licence · 91397 · Class 3
AFFINITY FUSION OXYGENATOR
Yes: licensed in Canada
Licence status Issued (active); first licensed May 31, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91397
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 31, 2013
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AFFINITY FUSION OXYGENATOR - OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE
- AFFINITY FUSION OXYGENATOR - OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
- AFFINITY FUSION OXYGENATOR - RECIRCULATION LINE
- AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CORTIVA BIOACTIVE SURFACE
- AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CORTIVA BIOACTIVE SURFACE AND CARDIOTOMY/VENOUS RESERVOR WITH BALANCE BIOSURFACE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.