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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K993248
Device Name AMPLATZER SIZING BALLOON
Applicant
Aga Medical Corp.
682 Mendelssohn Ave.
Plymouth,  MN  55427
Applicant Contact JODI L LOCHER
Correspondent
Aga Medical Corp.
682 Mendelssohn Ave.
Plymouth,  MN  55427
Correspondent Contact JODI L LOCHER
Regulation Number870.4450
Classification Product Code
MJN  
Date Received09/28/1999
Decision Date 07/12/2000
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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