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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K260508
Device Name LOBO Vascular Occlusion System
Applicant
Okami Medical, Inc.
8 Argonaut
Suite 100
Aliso Viejo,  CA  92656
Applicant Contact Cora Sim
Correspondent
Okami Medical, Inc.
8 Argonaut
Suite 100
Aliso Viejo,  CA  92656
Correspondent Contact Cora Sim
Regulation Number870.3300
Classification Product Code
KRD  
Date Received02/17/2026
Decision Date 04/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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