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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 K230051
Device Name 14F iSLEEVE™ Introducer Set
Applicant
Boston Scientific Corporation
One Scimed Place
Maple Grove,  MN  55311
Applicant Contact Kendall Lindenman
Correspondent
Boston Scientific Corporation
One Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Kendall Lindenman
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/06/2023
Decision Date 02/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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