Medical device licence · 14470 · Class 4
CSF-FLOW CONTROL SHUNT KITS & ASSEMBLIES
Yes: licensed in Canada
Licence status Issued (active); first licensed November 16, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 14470
- Licence holder
- Medtronic Inc.Minneapolis, MN, United States
- Risk class
- Class IV (highest risk)
- Licence type
- Device Group Family
- First licensed
- November 16, 1999
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CSF-SHUNT ASSEMBLY CONTOURED REGULAR (BARIUM-IMPREGNATED)
- CSF-SHUNT ASSEMBLY ULTRA SMALL (BARIUM)
- CSF-SHUNT ASSEMBLY ULTRA SMALL WITH INTEGRAL DELTA CHAMBER (BARIUM)
- CSF-SHUNT ASSEMBLY, CONTOURED SMALL (BARIUM-IMPREGNATED)
- CSF-SHUNT KIT, ULTRA SMALL (BARIUM-IMPREGNATED)
- CSF-SHUNT SNAP ASSEMBLY BUTTON
- CSF-SNAP SHUNT ASSEMBLY BUTTON (BARIUM-IMPREGNATED)
- CSF-SNAP SHUNT ASSEMBLY ULTRA SMALL (BARIUM-IMPREGNATED)
- CSF-SNAP SHUNT ASSEMBLY, CONTOURED SMALL (BARIUM)
- CSF-UNITIZED SHUNT KIT CONTOURED (BARIUM-IMPREGNATED)
- CSF-UNITIZED SHUNT KIT W/BIOGLIDE
- DELTA CHAMBER (BARIUM)
- DELTA SHUNT ASSEMBLY (BARIUM-IMPREGNATED)
- DELTA SHUNT ASSEMBLY NEONATAL (BARIUM-IMPREGNATED)
- DELTA SHUNT ASSEMBLY W/BIOGLIDE (BARIUM-IMPREGNATED)
- DELTA SNAP SHUNT ASSEMBLY (BARIUM)
- DELTA UNITIZED SHUNT ASSEMBLY
- NEONATAL DELTA SHUNT SNAP ASSEMBLY (BARIUM)
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 “csf-flow”. A notice may cover another product or only some lots: read it to see what it covers.
- Strata II, Delta, and CSF-Flow Control Valves and Shunts (2021-01-18)February 5, 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.