FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Thrombolex Nabs 510(k) Clearance for Catheter System

May 17, 2019
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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.

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