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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 K090659
Device Name ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY
Applicant
Medtronic, Inc.
8200 Coral Sea St. NE
Ms:Mvs11
Mounds View,  MN  55112
Applicant Contact BRUCE BACKLUND
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NE
Ms:Mvs11
Mounds View,  MN  55112
Correspondent Contact BRUCE BACKLUND
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/12/2009
Decision Date 03/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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