Okami Gets 510(k) Clearance for Vascular Occluder

December 18, 2020

Okami Medical has been granted 510(k) marketing clearance by the FDA for its LOBO-5 (low-profile braided occluder) vascular occluder system.

The flexible device is designed to quickly close peripheral arteries, including curved vessels, during surgeries to treat various conditions.

The LOBO-5 is intended for use in blood vessels 3 mm to 5 mm in diameter. Okami previously received clearance for its LOBO-3 system that is used in 1.5 mm to 3 mm vessels.

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