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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 K150876
Device Name Bead Block
Applicant
Biocompatibles UK , Ltd.
Chapman House, Weydon Ln.
Farnham,  GB GU9 8QL
Applicant Contact PEDRO GARCIA
Correspondent
Btg International, Inc.
Lakeview, Riverside Way, Watchmoor Park
Camberley, Surrey, Gu15 3yl,  GB
Correspondent Contact Simon Leppard
Regulation Number870.3300
Classification Product Code
KRD  
Subsequent Product Codes
HCG   NAJ  
Date Received04/01/2015
Decision Date 03/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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