Medical device licence · 85590 · Class 3
XCELA POWER INJECTABLE PORT
Yes: licensed in Canada
Licence status Issued (active); first licensed March 24, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85590
- Licence holder
- Navilyst Medical, Inc.Marlborough, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- March 24, 2011
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- XCELA POWER INJECTABLE PORT - LOW PROFILE TITANIUM PORT
- XCELA POWER INJECTABLE PORT - PLASTIC PORT
- XCELA POWER INJECTABLE PORT - PLASTIC/TITANIUM PORT
- XCELA POWER INJECTABLE PORT - STANDARD TITANIUM PORT
- XCELA POWER INJECTABLE PORT PLASTIC DUAL LUMEN PORT
- XCELA POWER INJECTABLE PORT PLASTIC/TITANIUM DUAL LUMEN PORT
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 “xcela”. A notice may cover another product or only some lots: read it to see what it covers.
- 8f Xcela Plus Implantable Ports & 8f Bioflo Plus Implantable Ports (2019-09-18)January 10, 2020 · Medical devices · Medical devices · Type II
- XCELA PICC WITH PASV VALVE TECHNOLOGY, SINGLE LUMEN, IR KIT, BIOFLOW PICC MST-70 KIT, BIOFLOW PICC IR-175 KIT, PICC CONVENIENCE KIT (2018-05-10)August 2, 2019 · Medical devices · Medical devices · Type II
- Xcela PICC with PASV Technology Convenience Kit (2017-10-17)October 27, 2017 · Medical devices · Medical devices · Type III
- Xcela and BioFlo PICC (2016-11-28)December 13, 2016 · 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.