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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 K080757
Device Name AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
Applicant
Aga Medical Corp.
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Applicant Contact RASHMI BHUSHAN
Correspondent
Aga Medical Corp.
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Correspondent Contact RASHMI BHUSHAN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/18/2008
Decision Date 04/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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