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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 K260606
Device Name Echo Large Bore Introducer Sheath
Applicant
Echo Medical, LLC
9 Executive Cir., Suite 290
Irvine,  CA  92614
Applicant Contact Steve Geist
Correspondent
Landon Consulting, LLC
20451 Whitetree Cir.
Huntington Beach,  CA  92646
Correspondent Contact Anna Landon
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/24/2026
Decision Date 04/29/2026
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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