Medical device licence · 95989 · Class 3
BIOFLO MIDLINE CATHETER
Yes: licensed in Canada
Licence status Issued (active); first licensed October 28, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95989
- Licence holder
- Spectrum VascularWhite Plains, NY, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- October 28, 2015
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOFLO MIDLINE CATHETER (W/ 2 GUIDEWIRES)
- BIOFLO MIDLINE CATHETER (W/ GUIDEWIRE)
- BIOFLO MIDLINE CATHETER (W/ STIFFENING STYLET AND GUIDEWIRE)
- BIOFLO MIDLINE CATHETER (W/ STIFFENING STYLET)
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 “bioflo”. A notice may cover another product or only some lots: read it to see what it covers.
- BioFlo Dialysis Catheter With Endexo TechnologyFebruary 19, 2026 · Gastroenterology and urology · Performance · Type II
- 8f Xcela Plus Implantable Ports & 8f Bioflo Plus Implantable Ports (2019-09-18)January 10, 2020 · Medical devices · Medical devices · Type II
- 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.