Medical device licence · 97548 · Class 2
FATHOM - 14 STEERABLE GUIDEWIRE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 17, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97548
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 17, 2016
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FATHOM-14 PRE-SHAPED
- FATHOM-14 STRAIGHT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.