Medical device licence · 66014 · Class 2
EMBOL-X KITS
No longer licensed: cancelled
Licence status Cancelled; first licensed October 1, 2004; ended January 23, 2018. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 66014
- Licence holder
- Edwards Lifesciences LlcIrvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- October 1, 2004
- Ended
- January 23, 2018
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMBOL-X KIT, DUAL FILTER
- EMBOL-X KIT, GLIDE CANNNULA WITH SUTRUE FLANGE AND FILTER
- EMBOL-X KIT, GLIDE CANNULA WITH SUTURE BUMP AND FILTER
- EMBOL-X KIT, SIZER KIT
- EMBOL-X KITS
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 “embol-x”. A notice may cover another product or only some lots: read it to see what it covers.
- Embol-X Arterial Cannula and Embol-X Kit, Glide Cannula with Suture Flange and Filter (2013-10-02)October 31, 2013 · 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.