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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 K163000
Device Name AMPLATZER TorqVue 45x45 Delivery Sheath
Applicant
AGA Medical Corporation (Wholly Owned by St. Jude Medical Co
5050 Nathan Lane
Plymouth,  MN  55442
Applicant Contact Mary Johnson
Correspondent
AGA Medical Corporation (Wholly Owned by St. Jude Medical Co
5050 Nathan Lane
Plymouth,  MN  55442
Correspondent Contact Mary Johnson
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/28/2016
Decision Date 12/23/2016
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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