Medical device licence · 100735 · Class 3
CORE M2 VASCULAR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 23, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100735
- Licence holder
- Volcano CorporationSan Diego, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 23, 2018
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONTROL CONSOLE II
- CORE M2 PANEL PC
- CORE M2 VASCULAR SYSTEM
- PATIENT INTERFACE MODULE
- SOFTWARE KIT V4.2, CORE M2
- SOFTWARE KIT V4.2, FIELD SERVICE, CORE M2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.