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Home » Okami Gets 510(k) Clearance for Vascular Occluder
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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