Okami Gets 510(k) Clearance for Vascular Occluder
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.