Thrombolex Nabs 510(k) Clearance for Catheter System

May 20, 2019 | News

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.

Recent Posts

Interim Data from the RAPID-PE Study Presented at TCT 2025

Interim Data from the RAPID-PE Study Presented at TCT 2025

New Britain, PA - (October 28th, 2025) - Thrombolex, Inc. presented the prespecified interim analysis from the first 50 patients in RAPID-PE, a prospective, multicenter U.S. study evaluating On-The-Table (OTT) pharmaco-mechanical lysis (PML) without any post procedure...

read more
RESCUE-II Study results published in JACC: Advances

RESCUE-II Study results published in JACC: Advances

New Britain, PA – (June 25, 2025) – Thrombolex, Inc., a medical device manufacturer committed to advancing solutions for the treatment of arterial and venous thromboembolic diseases, announced the publication of the results from the RESCUE-II Study in JACC: Advances....

read more