Medical device licence · 85 · Class 3
PORT-A-CATH II
Yes: licensed in Canada
Licence status Issued (active); first licensed August 31, 1998. It is in Health Canada’s list of active licences.
- Licence number
- 85
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- August 31, 1998
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PORT-A-CATH II DUAL-LUMEN SYSTEM
- PORT-A-CATH II FLUORO-FREE DUAL-LUMEN LOW PROFILE VENOUS ACCESS SYSTEM
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 “port-a-cath”. A notice may cover another product or only some lots: read it to see what it covers.
- Port-a-Cath II Implantable Venous Access System (2013-09-06)October 28, 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.