Penumbra’s RED 62 Reperfusion Catheter Gets FDA 510(k) Clearance

Alameda, Calif.-based Penumbra has received 510(k) clearance from the FDA for its RED 62 reperfusion catheter.

The catheter is intended for stroke management, using tracking and aspiration technology to remove occlusions in the hard-to-treat distal vessels.

The RED 62 is used along with the Penumbra Engine, which generates a vacuum to extract blood clots in acute ischemic stroke patients with large vessel occlusions.