Medical device licence · 13051 · Class 4
HOLTER VALVE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 15, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 13051
- Licence holder
- Integra Lifesciences Production CorporationMansfield, MA, United States
- Risk class
- Class IV (highest risk)
- Licence type
- System
- First licensed
- October 15, 1999
- Devices covered
- 18
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CEREBRAL CATHETER RESERVOIRS
- CODMAN DISTAL PERITONEAL CATHETER, BARIUM OPEN END
- CODMAN HOLTER ATRIAL CATHETER TYPE "A"
- CODMAN HOLTER ATRIAL CATHETER TYPE "B"
- CODMAN HOLTER VENTRICULAR CATHETER
- HOLTER MINI-VALVE
- HOLTER PERITONEAL CATHETER (SALMON DESIGN)
- HOLTER RICKHAM VENTRICULOSTOMY RESERVOIR W/ CATHETER
- HOLTER SALMON-RICKMAN VENTRICULOSTOMY RESERVOIR W/ CATHETER
- HOLTER TYPE"A" FIXATION & JOINING CONNECTOR
- HOLTER TYPE"B" FIXATION & JOINING CONNECTOR
- HOLTER TYPE"C" ATRIAL CATHETER
- HOLTER TYPE"E" ATRIAL CATHETER
- HOLTER TYPE"H" ATRIAL CATHETER
- HOLTER TYPE"T" FIXATION & JOINING CONNECTOR
- HOLTER VALVES
- HOLTER VENTRICULOSTOMY KITS
- IN-LINE SHUNT FILTER (HOFFMAN DESIGN)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.