Medical device licence · 92337 · Class 2
DIREXION TORQUEABLE MICROCATHETERS
Yes: licensed in Canada
Licence status Issued (active); first licensed November 21, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92337
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 21, 2013
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIREXION FATHOM-16 SYSTEM PRE-LOADED TORQUEABLE MICROCATHETER
- DIREXION HI-FLO FATHOM-16 SYSTEM PRE-LOADED TORQUEABLE MICROCATHETER
- DIREXION HI-FLO TORQUEABLE MICROCATHETER
- DIREXION HI-FLO TRANSEND-18 SYSTEM PRE-LOADED TORQUEABLE MICROCATHETER
- DIREXION TORQUEABLE MICROCATHETER
- DIREXION TRANSEND-14 SYSTEM PRE-LOADED TORQUEABLE MICROCATHETER
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 “direxion”. A notice may cover another product or only some lots: read it to see what it covers.
- Direxion and Direxion HI-FLO MicrocathetersOctober 1, 2026 · General hospital and personal use · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.