Medical device licence · 92872 · Class 4
TANDEMHEART SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed February 27, 2014; ended December 6, 2024. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 92872
- Licence holder
- Cardiacassist LlcArvada, CO, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- February 27, 2014
- Ended
- December 6, 2024
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- TANDEMHEART - CANNULA
- TANDEMHEART - ESCORT CONTROLLER
- TANDEMHEART - PUMP KIT
- TANDEMHEART INFUSION ACCESSORY PACK
- TANDEMHEART PROCEDURE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.