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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 K040243
Device Name BARD ATLAS PTA BALLOON DILATATION CATHETER
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Applicant Contact AYMEE R BERRY
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Correspondent Contact AYMEE R BERRY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/03/2004
Decision Date 02/13/2004
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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