Medical device licence · 70903 · Class 4
NON-NAVIGATIONAL CATHETERS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 20, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 70903
- Licence holder
- Biosense Webster, Inc.Irvine, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Family
- First licensed
- March 20, 2006
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CELSIUS FLTR BI-DIRECTIONAL ABLATION CATHETER
- CELSIUS FLTR UNI-DIRECTIONAL ABLATION CATHETER
- EZ STEER BI-DIRECTIONAL CATHETERS - THERMISTOR
- EZ STEER BI-DIRECTIONAL CATHETERS - THERMOCOUPLE
- EZ STEER BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER - THERMOCOOL
- THERMOCOOL SF UNI-DIRECTIONAL CATHETER
- THERMOCOOL*SF BI-DIRECTIONAL CATHETER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.