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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vascular, For Promoting Embolization
510(k) Number K031810
Device Name AMPLATZER VASCULAR PLUG
Applicant
Aga Medical Corp.
682 Mendelssohn Ave.
Plymouth,  MN  55427
Applicant Contact PATRICE M STROMBERG
Correspondent
Aga Medical Corp.
682 Mendelssohn Ave.
Plymouth,  MN  55427
Correspondent Contact PATRICE M STROMBERG
Regulation Number870.3300
Classification Product Code
KRD  
Date Received06/12/2003
Decision Date 09/09/2003
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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