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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K201118
Device Name Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
Applicant
Medtronic, Inc.
5290 California Ave.
Irvine,  CA  92617
Applicant Contact Jen Correa
Correspondent
Medtronic, Inc.
5290 California Ave.
Irvine,  CA  92617
Correspondent Contact Jen Correa
Regulation Number882.1620
Classification Product Code
GWM  
Subsequent Product Code
HCA  
Date Received04/27/2020
Decision Date 05/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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