Medical device licence · 93974 · Class 3
EMPRINT ABLATION SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 26, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93974
- Licence holder
- Covidien LlcChicopee, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 26, 2014
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EMPRINT ABLATION CART
- EMPRINT ABLATION FOOTSWITCH
- EMPRINT ABLATION GENERATOR WITH THERMOSPHERE TECHNOLOGY
- EMPRINT ABLATION PLANNING APPLICATION
- EMPRINT ABLATION PUMP
- EMPRINT ABLATION REUSABLE CABLE
- EMPRINT HP ABLATION CART
- EMPRINT HP ABLATION GENERATOR WITH THERMOSPHERE TECHNOLOGY 150W
- EMPRINT PERCUTANEOUS ANTENNA WITH THERMOSPHERE TECHNOLOGY LARGE SPHERICAL ABLATION ZONE
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 “emprint”. A notice may cover another product or only some lots: read it to see what it covers.
- Emprint Percutaneous Antenna with Thermosphere Technology Large Spherical Ablation Zone (2019-03-28)May 3, 2019 · Medical devices · Medical devices · Type II
- Emprint Percutaneous Antenna with Thermosphere Technology Large Spherical Ablation Zone (2018-11-16)January 11, 2019 · Medical devices · Medical devices · Type II
- Emprint Percutaneous Antenna With Thermoshere TechnologySeptember 5, 2017 · Medical devices · Type II
- EMPRINT PERCUTANEOUS ANTENNA WITH THERMOSPHERE TECHNOLOGY (2016-02-24)March 10, 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.