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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 K093476
Device Name AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120
Applicant
Aga Medical Corp.
5050 Nathan Ln. N.
Plymouth,  MN  55442
Applicant Contact AMANDA JOHNSON
Correspondent
Aga Medical Corp.
5050 Nathan Ln. N.
Plymouth,  MN  55442
Correspondent Contact AMANDA JOHNSON
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/09/2009
Decision Date 02/05/2010
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
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