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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
510(k) Number K122367
Device Name BARD PTV DILATATION CATHETER
Original Applicant
C.R. BARD, INC.
1625 w. third street
tempe,  AZ  85281
Original Contact erin fox
Regulation Number870.1250
Classification Product Code
OMZ  
Date Received08/06/2012
Decision Date 11/02/2012
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
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