www.fdanews.com/articles/191324-thrombolex-nabs-510k-clearance-for-catheter-system
Thrombolex Nabs 510(k) Clearance for Catheter System
May 16, 2019
The FDA has granted Thrombolex 510(k) clearance for its Bashir Endovascular Catheter, a device used to manage the infusion of fluids.
The device is used by physicians to control the infusion of specific fluids, such as thrombolytics, into a patient’s peripheral vasculature system—veins and arteries not in the chest and abdomen.
The system includes six expandable mini-infusion catheters, allowing the physician to deliver specified fluids in specific locations within the vasculature.