ApprovalTrail

Medical device licence · 1915 · Class 2

BALLOON DILATORS

Yes: licensed in Canada

Licence status Issued (active); first licensed March 16, 1999. It is in Health Canada’s list of active licences.
Licence number
1915
Licence holder
Wilson-Cook Medical, Inc.Winston Salem, NC, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
March 16, 1999
Devices covered
4

Devices on this licence

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

  • ECLIPSE TTC
  • QUANTUM TTC BALLOON DILATOR (COLONIC)
  • QUANTUM TTC BALLOON DILATOR (ESOPHAGEAL)
  • WILSON-COOK ACHALASIA BALLOON

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