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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 K243552
Device Name Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
Applicant
Integra Lifesciences Production Corporation
11 Cabot Blvd.
Mansfield,  MA  02048
Applicant Contact Kali Sacco
Correspondent
Integra Lifesciences Production Corporation
11 Cabot Blvd.
Mansfield,  MA  02048
Correspondent Contact Kali Sacco
Regulation Number882.5550
Classification Product Code
JXG  
Date Received11/15/2024
Decision Date 08/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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