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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K172035
Device Name EKOS ultrasound EVD Device, EVD Control Unit
Applicant
Btg International, Inc.
11911 N. Creek Pkwy. S.
Bothell,  WA  98011
Applicant Contact Brit Baird
Correspondent
Btg International, Inc.
11911 N. Creek Pkwy. S.
Bothell,  WA  98011
Correspondent Contact Jocelyn Kersten
Regulation Number882.5550
Classification Product Code
JXG  
Date Received07/05/2017
Decision Date 03/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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