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510(k) K172571

ULTRASCORE Focused Force PTA Balloon by C. R. Bard — Product Code PNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2017
Date Received
August 28, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous, Cutting/Scoring
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

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