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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 K070238
Device Name AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
Original Applicant
AGA MEDICAL CORP.
682 mendelssohn ave.
plymouth,  MN  55427
Original Contact david d cox
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/25/2007
Decision Date 02/28/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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