ApprovalTrail

Medical device licence · 298 · Class 4

HAKIM SHUNT VALVES ONLY

Yes: licensed in Canada

Licence status Issued (active); first licensed November 13, 1998. It is in Health Canada’s list of active licences.
Licence number
298
Licence holder
Integra Lifesciences Production CorporationMansfield, MA, United States
Risk class
Class IV (highest risk)
Licence type
Device Group Family
First licensed
November 13, 1998
Devices covered
17

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • CODMAN HAKIM PRECISION FIXED PRESSURE VALVE CYLINDRICAL VALVE
  • CODMAN HAKIM PRECISION FIXED PRESSURE VALVE CYLINDRICAL VALVE WITH PRECHAMBER
  • CODMAN HAKIM PRECISION FIXED PRESSURE VALVE IN-LINE VALVE
  • CODMAN HAKIM PRECISION FIXED PRESSURE VALVE IN-LINE VALVE WITH SIPHONGUARD DEVICE
  • CODMAN HAKIM PRECISION FIXED PRESSURE VALVE MICRO VALVE
  • CODMAN HAKIM PRECISION FIXED PRESSURE VALVE RIGHT ANGLE VALVE
  • CODMAN HAKIM PRECISION FIXED PRESSURE VALVE RIGHT ANGLE VALVE WITH SIPHONGUARD DEVICE
  • CODMAN HAKIM PROGRAMMABLE VALVE CYLINDRICAL VALVE
  • CODMAN HAKIM PROGRAMMABLE VALVE CYLINDRICAL VALVE WITH INTEGRAL CONNECTORS
  • CODMAN HAKIM PROGRAMMABLE VALVE CYLINDRICAL VALVE WITH PRECHAMBER
  • CODMAN HAKIM PROGRAMMABLE VALVE IN-LINE VALVE
  • CODMAN HAKIM PROGRAMMABLE VALVE IN-LINE VALVE WITH SIPHONGUARD DEVICE
  • CODMAN HAKIM PROGRAMMABLE VALVE MICRO II VALVE
  • CODMAN HAKIM PROGRAMMABLE VALVE MICRO VALVE WITH RICKHAM RESERVOIR
  • CODMAN HAKIM PROGRAMMABLE VALVE RIGHT ANGLE VALVE
  • CODMAN HAKIM PROGRAMMABLE VALVE RIGHT ANGLE VALVE WITH SIPHONGUARD DEVICE
  • CODMAN HAKIM PROGRAMMABLE VAVLE MICRO VALVE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.