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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 K080428
Device Name ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY
Applicant
MEDTRONIC INC.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW,  MN  55112
Applicant Contact MARLENE PETERSON
Correspondent
MEDTRONIC INC.
8200 CORAL SEA STREET NE
MS MV S11
MOUNDS VIEW,  MN  55112
Correspondent Contact MARLENE PETERSON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/19/2008
Decision Date 12/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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