Medical device licence · 106509 · Class 2
FLEXIVA PULSE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 9, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106509
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 9, 2021
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLEXIVA PULSE
- FLEXIVA PULSE TRACTIP
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 “flexiva”. A notice may cover another product or only some lots: read it to see what it covers.
- Flexiva™ Pulse Tractip™June 14, 2023 · 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.