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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 K123990
Device Name SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
Applicant
Medtronic Vascular
3576 Unocal Place
Santa Rosa,  CA  95403
Applicant Contact KELLEY LAMKE
Correspondent
Medtronic Vascular
3576 Unocal Place
Santa Rosa,  CA  95403
Correspondent Contact KELLEY LAMKE
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/26/2012
Decision Date 04/26/2013
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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