ApprovalTrail

Medical device licence · 1687 · Class 2

ESOPHAGEAL DILATORS

Yes: licensed in Canada

Licence status Issued (active); first licensed March 1, 1999. It is in Health Canada’s list of active licences.
Licence number
1687
Licence holder
Diversatek HealthcareHighlands Ranch, CO, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
March 1, 1999
Devices covered
7

Devices on this licence

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

  • DILATION SYSTEM 1214 SERIES
  • DISPOSABLE OVER THE GUIDEWIRE ESOPHAGEAL DILATOR
  • ESOPHAGEAL DILATOR, MERCURY FILLED HURST STYLE
  • ESOPHAGEAL DILATOR, OVER THE GUIDEWIRE STYLE
  • ESOPHAGEAL DILATOR, TUNGSTEN FILLED HURST STYLE
  • ESOPHAGEAL DILATOR, TUNGSTEN FILLED MALONEY STYLE
  • SAFEGUIDE GUIDEWIRE WITH SPRING TIP

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