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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 K083214
Device Name AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
Original Applicant
AGA MEDICAL CORP.
5050 nathan lane north
plymouth,  MN  55442
Original Contact diane carroll
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/31/2008
Decision Date 05/12/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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