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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K253526
Device Name NAMIC Dilator and Sheath
Applicant
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Applicant Contact Payal Solanki
Correspondent
Medline Industries, LP
Three Lakes Dr.
Northfiled,  IL  60093
Correspondent Contact Payal Solanki
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/13/2025
Decision Date 07/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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