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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 K250075
Device Name Medtronic Stedi Extra Support Guidewire
Applicant
Medtronic, Inc.
710 Medtronic Pkwy.
Minneapolis,,  MN  55432
Applicant Contact Hillary Barasa
Correspondent
Medtronic, Inc.
710 Medtronic Pkwy.
Minneapolis,,  MN  55432
Correspondent Contact Hillary Barasa
Regulation Number870.1330
Classification Product Code
DQX  
Date Received01/10/2025
Decision Date 06/13/2025
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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