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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon Aortic Valvuloplasty
510(k) Number K133569
Device Name TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
Applicant
Bard Peripheral Vascular, Inc.
1307 S. Mary Ave.
Suite 280
Sunnyvale,  CA  94087
Applicant Contact TIFFINI DIAGE
Correspondent
Bard Peripheral Vascular, Inc.
1307 S. Mary Ave.
Suite 280
Sunnyvale,  CA  94087
Correspondent Contact TIFFINI DIAGE
Regulation Number870.1255
Classification Product Code
OZT  
Date Received11/20/2013
Decision Date 12/20/2013
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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