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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 K120120
Models 9-TV-LA1-XXF-080(XX=09,10,12,13,OR 14), 9-TV-LA2-XXF-080 (XX09,10,12,13,OR 14), 9-TV45X45-14F-100
Device Name AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH
Original Applicant
AGA MEDICAL CORPORATION
5050 nathan lane
plymouth,  MN  55433
Original Contact rashmi bhushan
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/17/2012
Decision Date 03/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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