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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 K131002
Device Name VIDA PTV DILATATON CATHETER
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact AARON CONOVALOFF
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact AARON CONOVALOFF
Regulation Number870.1250
Classification Product Code
OMZ  
Date Received04/10/2013
Decision Date 07/02/2013
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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