Medical device licence · 105889 · Class 4
OMNIWIRE PRESSURE GUIDE WIRE
Yes: licensed in Canada
Licence status Issued (active); first licensed February 26, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105889
- Licence holder
- Volcano CorporationSan Diego, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- February 26, 2021
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OMNIWIRE PRESSURE GUIDE WIRE J-TIP
- OMNIWIRE PRESSURE GUIDE WIRE STRAIGHT TIP
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 “omniwire”. A notice may cover another product or only some lots: read it to see what it covers.
- Omniwire Pressure Guide Wire J-TipJune 13, 2022 · Cardiovascular · Sterility · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.