Device Dossier

CERELINK ICP Sensor Metal Skull Bolt Kit - Intracerebral sensor catheter

Device Dossier for CERELINK ICP Sensor Metal Skull Bolt Kit - Intracerebral sensor catheter (Intracerebral sensor catheter, Class III, sponsor Integra…

Intended purpose

Use of the CERELINK ICP Sensor Metal Skull Bolt Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only

Functional description

Consists of an intracranial pressure (ICP) sensor, skull bolt with integrated compression cap and optional washer, obturator/dura pierce, and drill bit with depth guide and hex wrench. The ICP Sensor is a tube with a microminiature strain gauge pressure transducer element mounted at one end and an electrical connector at the other end. It is designed for use with an intracranial pressure monitoring device supplied separately.

TGA Public Summary