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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 K072313
Device Name AMPLATZER TORQVUE DELIVERY SYSTEM
Applicant
Aga Medical Corp.
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Applicant Contact PATRICIA A LAFORTE
Correspondent
Aga Medical Corp.
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Correspondent Contact PATRICIA A LAFORTE
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/17/2007
Decision Date 11/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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