Cleared Traditional

K223177 - Highlander™ 014 PTA Balloon Dilatation Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223177 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
101d
Days
Class 2
Risk

K223177 is an FDA 510(k) clearance for the Highlander™ 014 PTA Balloon Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 20, 2023 after a review of 101 days - within the typical 510(k) review window.

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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K223177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2022
Decision Date January 20, 2023
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 401
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K223177.
Armada™ 14 NC PTA Catheter
K252512 · Abbott Medical · Feb 2026
Amethyst HP PTA OTW 0.035 Catheter
K251915 · Natec Medical , Ltd. · Dec 2025
Passeo-35 Xeo Peripheral Dilatation Catheter
K250706 · Biotronik, Inc. · Apr 2025
Parafleet SC 014 PTA Balloon Dilatation Catheter
K243704 · Brosmed Medical Co., Ltd. · Feb 2025
Amethyst HP PTA OTW 0.035 Catheter
K241040 · Natec Medical , Ltd. · Dec 2024
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
K242419 · Creagh Medical Ltd. Dba Surmodics, Inc. · Nov 2024