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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 K250468
Device Name iSLEEVE Introducer Set
Applicant
Boston Scientific
One Scimed Pl
Maple Grove,  MN  55311
Applicant Contact Elizabeth LaDriere
Correspondent
Boston Scientific
One Scimed Pl
Maple Grove,  MN  55311
Correspondent Contact Elizabeth LaDriere
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/18/2025
Decision Date 03/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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