ApprovalTrail

Medical device licence · 60688 · Class 3

CARTO XP EP NAVIGATION SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed October 11, 2002; ended October 28, 2021. It is in Health Canada’s archive of licences no longer in force.
Licence number
60688
Licence holder
Biosense Webster (Israel) Ltd.Yokneam, Israel
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
October 11, 2002
Ended
October 28, 2021
Devices covered
10

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • CARTO XP EP NAVIGATION SYSTEM - CARTOMERGE IMAGE INTEGRATION MODULE
  • CARTO XP EP NAVIGATION SYSTEM - CARTOSYNC SOFTWARE MODULE
  • CARTO XP EP NAVIGATION SYSTEM - MAIN UNIT
  • CARTO XP EP NAVIGATION SYSTEM - VERSION 10 - COMPLETE SYSTEM
  • CARTO XP EP NAVIGATION SYSTEM - VERSION 10 - UPGRADE KIT
  • CARTO XP EP NAVIGATION SYSTEM VERSION 10
  • CARTO XP EP NAVIGATION SYSTEM, VERSION 9 - CARTOMERGE+ KIT (MODULE) FOR V9
  • CARTO XP EP NAVIGATION SYSTEM, VERSION 9 - COMPLETE SYSTEM
  • CARTO XP EP NAVIGATION SYSTEM, VERSION 9 - SOFTWARE VERSION V9
  • CARTO XP EP NAVIGATION SYSTEM, VERSION 9 - ULTRASOUND KIT (MODULE)

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.

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.