Cleared Special

ULTRASCORE Focused Force PTA Balloon

K172571 · C. R. Bard · Cardiovascular
Sep 2017
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K172571 is an FDA 510(k) clearance for the ULTRASCORE Focused Force PTA Balloon, a Catheter, Percutaneous, Cutting/scoring (Class II — Special Controls, product code PNO), submitted by C. R. Bard (Tempe, US). The FDA issued a Cleared decision on September 22, 2017, 25 days after receiving the submission on August 28, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K172571 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2017
Decision Date September 22, 2017
Days to Decision 25 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code PNO — Catheter, Percutaneous, Cutting/scoring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material

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