Medical device licence · 99212 · Class 4
JETSTREAM ATHERECTOMY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 30, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99212
- Licence holder
- Boston Scientific CorporationWatertown, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- May 30, 2017
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- JETSTREAM ATHERECTOMY CATHETER
- JETSTREAM PV ATHERECTOMY SYSTEM CONSOLE
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 “jetstream”. A notice may cover another product or only some lots: read it to see what it covers.
- Forte Gamma Camera with Jetstream AZ (2019-09-25)October 11, 2019 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.