Medical device licence · 79488 · Class 2
INTRODUCER SHEATH SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 9, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79488
- Licence holder
- Edwards Lifesciences LlcIrvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- April 9, 2009
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ASCENDRA 2 INTRODUCER SHEATH SET
- ASCENDRA INTRODUCER SHEATH SET
- ASCENDRA+ INTRODUCER SHEATH SET
- EDWARDS EXPANDABLE INTRODUCER SHEATH SET
- EXPANDABLE INTRODUCER SHEATH SET
- NOVAFLEX INTRODUCER SHEATH SET
- RETROFLEX 3 INTRODUCER SHEATH SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.