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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 K091793
Device Name AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54
Applicant
Aga Medical Corp.
5050 Nathan Ln. N.
Plymouth,  MN  55442
Applicant Contact DIANE CARROLL
Correspondent
Aga Medical Corp.
5050 Nathan Ln. N.
Plymouth,  MN  55442
Correspondent Contact DIANE CARROLL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/17/2009
Decision Date 07/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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