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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Cutting/Scoring
510(k) Number K172571
Device Name ULTRASCORE Focused Force PTA Balloon
Applicant
C. R. Bard
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact Jonathan Holmes
Correspondent
C. R. Bard
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact Jonathan Holmes
Regulation Number870.1250
Classification Product Code
PNO  
Date Received08/28/2017
Decision Date 09/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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