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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 K180785
Device Name iSLEEVE Introducer Set
Applicant
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55446
Applicant Contact Toni Guidarelli
Correspondent
Boston Scientific Corporation
Three Scimed Place
Maple Grove,  MN  55446
Correspondent Contact Toni Guidarelli
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/26/2018
Decision Date 06/22/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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