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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 K203025
Device Name LOBO Vascular Occlusion System (model LOBO-5)
Applicant
Okami Medical
8 Argonut Suite 100
Aliso Viejo,  CA  92656
Applicant Contact Jill Delsman
Correspondent
Okami Medical
8 Argonut Suite 100
Aliso Viejo,  CA  92656
Correspondent Contact Jill Delsman
Regulation Number870.3300
Classification Product Code
KRD  
Date Received10/02/2020
Decision Date 11/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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