Medical device licence · 9745 · Class 4
FOGARTY CATHETER
Yes: licensed in Canada
Licence status Issued (active); first licensed August 12, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 9745
- Licence holder
- Edwards Lifesciences LlcIrvine, CA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Single Device
- First licensed
- August 12, 1999
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FOGARTY ADH CLOT CATHETER
- FOGARTY ARTERIAL EMBOLECTOMY CATHETERS
- FOGARTY GRAFT THROMBECTOMY CATHETER
- FOGARTY OCCLUSION CATHETER
- FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
- FOGARTY VENOUS THROMBECTOMY CATHETERS
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 “fogarty”. A notice may cover another product or only some lots: read it to see what it covers.
- Fogarty Catheters (2019-03-27)May 3, 2019 · 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.