www.fdanews.com/articles/204821-irras-gains-ce-mark-for-its-enhanced-irraflow-dual-lumen-catheter
Irras Gains CE Mark for Its Enhanced Irraflow Dual-Lumen Catheter
October 13, 2021
Stockholm, Sweden-based Irras has received a CE mark certification for its Irraflow 2.0 dual-lumen catheter from Dekra, the company’s Notified Body.
The Irraflow system performs intracranial fluid exchange by combining controlled irrigation and fluid drainage to better manage neurocritical care patients.
The Irraflow 2.0 catheter includes improved kink resistance, which improves deliverability, and an upgraded dual-lumen design that improves irrigation and drainage rates, the company said.
The catheter was previously cleared for marketing in the United States.