Cleared Special

K172571 - ULTRASCORE Focused Force PTA Balloon

K172571 is the FDA 510(k) clearance for ULTRASCORE Focused Force PTA Balloon by C. R. Bard. It is a Class 2 Cardiovascular device (product code PNO) cleared through the Special 510(k) pathway after a 25-day FDA review.

K172571 · C. R. Bard · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
25d
Days
Class 2
Risk

K172571 is an FDA 510(k) clearance for the ULTRASCORE Focused Force PTA Balloon. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by C. R. Bard (Tempe, US). The FDA issued a Cleared decision on September 22, 2017 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C. R. Bard devices

Submission Details

510(k) Number K172571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PNO Catheter, Percutaneous, Cutting/scoring
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PNO Catheter, Percutaneous, Cutting/scoring

All 21
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K172571.
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Serranator PTA Serration Balloon Catheter
K193181 · Cagent Vascular, LLC · Apr 2020
Scoreflex PTA Scoring Balloon Catheter
K182713 · Orbusneich Medical Trading, Inc. · Jun 2019
UltraScore Focused Force PTA Balloon
K163420 · Bard Peripheral Vascular, Inc. · Jun 2017
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322 · Cook Incorporated · Mar 2015
VASCUTRAK PTA DILATATION CATHETER
K103459 · C.R. Bard, Inc. · Dec 2010