Medical device licence · 84009 · Class 3
GORE VIABIL BILIARY ENDOPROSTHESIS
Yes: licensed in Canada
Licence status Issued (active); first licensed September 29, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84009
- Licence holder
- W. L. Gore & Associates, Inc.Flagstaff, AZ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- September 29, 2010
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GORE VIABIL BILIARY ENDOPROSTHESIS - NON-REMOVABLE DEVICES, PERCUTAN DELIV.
- GORE VIABIL BILIARY ENDOPROSTHESIS - REMOVABLE DEVICES, ENDOSCOPIC DELIVERY
- GORE VIABIL BILIARY ENDOPROSTHESIS - REMOVEABLE DEVICES PERCUTANEOUS DELI.
- GORE VIABIL BILIARY ENDOPROSTHESIS -NON-REMOVABLE DEVICES, ENDOSCOPIC DELI.
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.