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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K192712
Device Name Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter
Applicant
Medtronic, Inc.
Parkmore Business Park W.
Galway H91 Vy19,  IE
Applicant Contact Sharon Fahy
Correspondent
Medtronic, Inc.
Parkmore Business Park W.
Galway H91 Vy19,  IE
Correspondent Contact Nicola Reidy
Regulation Number870.1250
Classification Product Code
DQY  
Date Received09/27/2019
Decision Date 08/03/2020
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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