ApprovalTrail

Medical device licence · 88728 · Class 2

SIZER SETS

Yes: licensed in Canada

Licence status Issued (active); first licensed April 23, 2012. It is in Health Canada’s list of active licences.
Licence number
88728
Licence holder
Medtronic Inc.Minneapolis, MN, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
April 23, 2012
Devices covered
13

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • 3F AORTIC BIOPROSTHESIS SIZER
  • MECHANICAL HEART VALVE SIZERS
  • SIMUFORM POLYSULFONE SIZERS
  • SIMULUS 750 FLEXIBLE RING/BAND ACCESSORY KIT
  • SIMULUS 751 FLEXIBLE RING/BAND POLYSULFONE SIZER SET
  • SIMULUS 755 FLEXIBLE RING/BAND ROBOTIC ACCESSORY KIT
  • SIMULUS 850 SEMI-RIGID RING/BAND ACCESSORY KIT
  • SIMULUS 851 SEMI RIGID RING/BAND POLYSULFONE SIZER SET
  • SIMULUS 856 SEMI-RIGID RING/BAND SILICONE SIZER SET
  • SIMUPLUS POLYSULFONE SIZERS
  • SIMUPLUS SILICONE SIZERS
  • TRI-AD 2.0 ADAMS TRICUSPID BAND SIZER SET
  • TRI-AD SIZERS

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.