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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 K260012
Device Name UltraScore™ Focused Force PTA Balloon
Applicant
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact Laurissa Brantley
Correspondent
Bard Peripheral Vascular, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Correspondent Contact Laurissa Brantley
Regulation Number870.1250
Classification Product Code
PNO  
Date Received01/05/2026
Decision Date 02/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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