Cleared Traditional

K163420 - UltraScore Focused Force PTA Balloon

K163420 is an FDA 510(k) clearance for UltraScore Focused Force PTA Balloon, manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Traditional 510(k) pathway after a 190-day FDA review.

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

K163420 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 Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on June 14, 2017 after a review of 190 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bard Peripheral Vascular, Inc. devices

FDA 510(k) Submission Details - K163420

510(k) Number K163420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNO Device Classification - Class 2, Special Controls

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 20
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K163420.
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
K193495 · Transit Scientific · May 2020
Serranator PTA Serration Balloon Catheter
K193181 · Cagent Vascular, LLC · Apr 2020
Scoreflex PTA Scoring Balloon Catheter
K182713 · Orbusneich Medical Trading, Inc. · Jun 2019
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322 · Cook Incorporated · Mar 2015
VASCUTRAK PTA DILATATION CATHETER
K103459 · C.R. Bard, Inc. · Dec 2010
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
K070951 · Boston Scientific · Jun 2007