Medical device licence · 76775 · Class 2
VALVE SIZERS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 7, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76775
- Licence holder
- Edwards Lifesciences LlcIrvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 7, 2008
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AORTIC TRUE-SIZE OBTURATOR
- MITRAL ANNULOPLASTY RING SIZER
- MITRAL BARREL SIZER
- MITRAL REPLICA SIZER
- MITRAL SIZER/HANDLE TRAY
- VALVE SIZER
- VALVE SIZER, TRICUSPID
- VALVE SIZERS FOR MODEL 7300TFX
- VALVE SIZERS FOR PHYSIO II RING MODEL 5200
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.