Device Dossier
EDM Lumbar Catheter - Catheter, cerebrospinal
Device Dossier for EDM Lumbar Catheter - Catheter, cerebrospinal (Catheter, cerebrospinal, Class III, sponsor Medtronic). ARTG record, intended purpose,…
- GMDN category: Catheter, cerebrospinal
Intended purpose
The EDM Lumbar Catheters are designed for use as the proximal component for Cerebrospinal Fluid (CSF) Drainage and or monitoring from the lumbar subarachnoid space.
Functional description
EDM lumbar Catheters are fabricated from silicone elastomer tubing impregnated with barium sulfate to provide radiopacity. A PTFE coated SS guidewire with adjustable stop is provided to facillitate placement. The lumbar catheter design, guidewire with adjustable stop and the 14 gauge Tuohy needle allow for percutaneous placement without need for laminectomy. Fixation tabs, luer connector with cap and strain relief is also provided.