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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
Applicant
C.R. Bard, Inc.
1625 W Third St.
Tempe,  AZ  85281
Applicant Contact ERIN FOX
Correspondent
C.R. Bard, Inc.
1625 W Third St.
Tempe,  AZ  85281
Correspondent Contact ERIN FOX
Regulation Number870.1250
Classification Product Code
OMZ  
Date Received08/06/2012
Decision Date 11/02/2012
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
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