The FDA grants 510(k) clearance to Medtronic’s Affinity Fusion blood oxygenation systems, designed to replicate the lungs’ function during open heart surgeries.

Medtronic (NYSE:MDT) said the FDA granted 510(k) clearance for its Affinity Fusion blood oxygenator, used during open heart surgery to replace the function of the lungs.

The Minneapolis-area medical device company, which is the world’s largest pure-play medtech maker, said the Affinity Fusion is designed to filter a patient’s blood to remove particles and air during oxygenation.

The device also includes what Medtronic claims is “a first-of-its-kind curved venous inlet tube” designed to reduce blood flow turbulence, according to a press release.