Medical device licence · 107952 · Class 2
VIPER BALLOON DILATOR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 7, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107952
- Licence holder
- Diversatek HealthcareHighlands Ranch, CO, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 7, 2022
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- VIPER DILATION SYRINGE / GAUGE (NON-STERILE)
- VIPER FIXED WIRE BALLOON DILATOR
- VIPER WIRE GUIDED BALLOON DILATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.