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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
Model 2045-11, 2245-12, 2445-12
Device Name TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA
Original Applicant
LOMA VISTA MEDICAL
1307 south mary ave, ste 280
sunnyvale,  CA  94087
Original Contact tiffini diage
Regulation Number870.1250
Classification Product Code
OZT  
Date Received04/10/2012
Decision Date 10/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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