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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 K121083
Device Name TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA
Applicant
Loma Vista Medical
1307 S. Mary Ave.
Suite 280
Sunnyvale,  CA  94087
Applicant Contact TIFFINI DIAGE
Correspondent
Loma Vista Medical
1307 S. Mary Ave.
Suite 280
Sunnyvale,  CA  94087
Correspondent Contact TIFFINI DIAGE
Regulation Number870.1255
Classification Product Code
OZT  
Date Received04/10/2012
Decision Date 10/11/2012
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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