Medical device licence · 72577 · Class 3
WALLFLEX BILIARY RX STENT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 20, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 72577
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- October 20, 2006
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- WALLFLEX BILIARY PLUS RX FULLY COVERED STENT SYSTEM
- WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM
- WALLFLEX BILIARY RX PARTIALLY COVERED STENT SYSTEM
- WALLFLEX BILIARY RX UNCOVERED STENT SYSTEM
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “wallflex”. A notice may cover another product or only some lots: read it to see what it covers.
- WallFlex™ Esophageal Fully Covered/ Partially Covered Stent SystemsAugust 21, 2024 · General and plastic surgery - Gastroenterology and urology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.