SurModics Wins 510k Clearance and CE Mark for Balloon Dilation Catheter

SurModics won both a 510(k) clearance from the FDA and a CE Mark in the European Union for its 0.014" low-profile percutaneous transluminal angioplasty balloon dilation catheter.

The device includes the company’s Serene hydrophilic coating for low friction and particulates.

SurModics said it plans to launch the device in the coming months.