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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 K152054
Device Name Confida Adaptive Sheath
Applicant
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis,  MN  55432
Applicant Contact Matthew Lobeck
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/23/2015
Decision Date 08/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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