Medical device licence · 92282 · Class 2
HEARTSPAN STEERABLE INTRODUCER
Yes: licensed in Canada
Licence status Issued (active); first licensed November 8, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 92282
- Licence holder
- Merit Medical Systems Inc.Malvern, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 8, 2013
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HEARTSPAN STEERABLE INTRODUCER
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 “heartspan”. A notice may cover another product or only some lots: read it to see what it covers.
- HeartSpan? Transseptal Needles (2021-01-19)August 10, 2021 · 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.