Cleared Traditional

UltraScore Focused Force PTA Balloon

K163420 · Bard Peripheral Vascular, Inc. · Cardiovascular
Jun 2017
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K163420 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 Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on June 14, 2017, 190 days after receiving the submission on December 6, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K163420 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2016
Decision Date June 14, 2017
Days to Decision 190 days
Submission Type Traditional
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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