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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 K123153
Device Name ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT
Applicant
Medtronic, Ireland
Parkmore Business Park W.
Galway,  IE EL
Applicant Contact DEIRDRE MCMAHON
Correspondent
Medtronic, Ireland
Parkmore Business Park W.
Galway,  IE EL
Correspondent Contact DEIRDRE MCMAHON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/09/2012
Decision Date 04/09/2013
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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