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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 K261004
Device Name Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)
Applicant
Integra Lifesciences Production Corporation
11 Cabot Blvd.
Mansfield,  MA  02048
Applicant Contact Leigh Anne Diener
Correspondent
Integra Lifesciences Production Corporation
11 Cabot Blvd.
Mansfield,  MA  02048
Correspondent Contact Leigh Anne Diener
Regulation Number882.5550
Classification Product Code
JXG  
Date Received03/26/2026
Decision Date 06/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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