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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 K171866
Device Name Sentrant Introducer Sheath with Hydrophilic Coating
Applicant
Medtronic Vascular, Inc.
3576 Unocal Pl.
Santa Rosa,  CA  95403
Applicant Contact Wee Wen Leow
Correspondent
Medtronic Vascular, Inc.
3576 Unocal Pl.
Santa Rosa,  CA  95403
Correspondent Contact Wee Wen Leow
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/22/2017
Decision Date 12/20/2017
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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