Medical device licence · 101978 · Class 4
OPTIMA COIL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 26, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101978
- Licence holder
- Balt Usa, LlcIrvine, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Group Family
- First licensed
- October 26, 2018
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENDOVASCULAR EMBOLIZATION COIL OPTIBLOCK
- ENDOVASCULAR EMBOLIZATION COIL OPTIBLOCK (LE)
- ENDOVASCULAR EMBOLIZATION COIL OPTIBLOCK MINI
- ENDOVASCULAR EMBOLIZATION COIL OPTIFILL
- ENDOVASCULAR EMBOLIZATION COIL OPTIFILL MINI
- ENDOVASCULAR EMBOLIZATION COIL OPTIMAX COMPLEX SOFT
- ENDOVASCULAR EMBOLIZATION COIL OPTIMAX COMPLEX SUPER SOFT
- ENDOVASCULAR EMBOLIZATION COIL OPTIMAX HELICAL SOFT
- ENDOVASCULAR EMBOLIZATION COIL OPTIMAX HELICAL SUPERSOFT
- ENDOVASCULAR EMBOLIZATION COIL OPTIPAX
- ENDOVASCULAR EMBOLIZATION COIL OPTIPAX MINI
- ENDOVASCULAR EMBOLIZATION COIL, COMPLEX-10 SOFT
- ENDOVASCULAR EMBOLIZATION COIL, COMPLEX-10 STANDARD
- ENDOVASCULAR EMBOLIZATION COIL, COMPLEX-10 SUPERSOFT
- ENDOVASCULAR EMBOLIZATION COIL, COMPLEX-18
- ENDOVASCULAR EMBOLIZATION COIL, HELICAL-10 SOFT
- ENDOVASCULAR EMBOLIZATION COIL, HELICAL-10 STANDARD
- ENDOVASCULAR EMBOLIZATION COIL, HELICAL-10 SUPERSOFT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.