Flume Gets FDA’s 510(k) Clearance for Indwelling Urinary Catheter

Flume Catheter has received the FDA’s 510(k) clearance for its namesake device, which is an indwelling urinary catheter.

“The balloon is designed to address some key shortcomings of the traditional Foley catheter design,” said John Havard, founder of the London, UK-based company.

“When inflated, the Flume balloon envelops the tip of the catheter so that the emptying bladder makes contact with the flexible balloon surface rather than the rigid catheter tip,” Havard said. “The drainage ports are then deliberately inset and positioned at its base.”