Medical device licence · 97253 · Class 2
CARTO ENT SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed July 8, 2016; ended October 25, 2017. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 97253
- Licence holder
- Biosense Webster (Israel) Ltd.Yokneam, Israel
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 8, 2016
- Ended
- October 25, 2017
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARTO ENT SYSTEM: DISPLAY MONITOR
- CARTO ENT SYSTEM: FIELD RING
- CARTO ENT SYSTEM: INSTRUMENT HUB
- CARTO ENT SYSTEM: MAIN UNIT AND ACCESSORIES
- CARTO ENT SYSTEM: NAVIGATION CONSOLE
- CARTO ENT SYSTEM: PATIENT TRACKER
- CARTO ENT SYSTEM: POWER SUPPLY
- CARTO ENT SYSTEM: REGISTRATION PROBE
- CARTO ENT SYSTEM: SYSTEM WORKSTATION
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 “carto”. A notice may cover another product or only some lots: read it to see what it covers.
- CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (2021-02-25)March 18, 2021 · 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.