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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K150465
Device Name Medtronic Confida Brecker Guidewire
Applicant
Medtronic CoreValve, LLC.
3576 Unocal Place
Santa Rosa,  CA  95403
Applicant Contact Genevieve Balutowski Dunbar
Correspondent
Medtronic CoreValve, LLC.
3576 Unocal Place
Santa Rosa,  CA  95403
Correspondent Contact Matthew Lobeck
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/23/2015
Decision Date 08/03/2015
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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