FDA Clears Surmodics’ Dilatation Catheter

Surmodics has received the FDA’s 510(k) clearance for its Sublime Radial Access 0.014 rapid-exchange dilatation catheter.

The catheter is cleared for use in percutaneous transluminal angioplasty procedures to unblock blood vessels and restore normal blood flow.

The device is inserted into the wrist’s radial artery to enable below-the-knee access. At 250 centimeters, it has the longest working length of any FDA-cleared dilatation catheter, the company said.