Home » SurModics Receives FDA Clearance for Balloon Dilation Catheter
SurModics Receives FDA Clearance for Balloon Dilation Catheter
Devices Submissions and Approvals
The FDA granted SurModics 510(k) clearance for its 0.18” low-profile percutaneous transluminal angioplasty balloon dilation catheter.
The catheter combines balloon technologies with Surmodics’ proprietary, low-friction, low-particulate Serene hydrophilic coating for tracking and legion crossing performance.
The device is indicated for use in peripheral vascular applications ranging from 2mm to 10mm diameter.