Cleared Traditional

K223177 - Highlander 014 PTA Balloon Dilatation C...

K223177 is the FDA 510(k) clearance for Highlander 014 PTA Balloon Dilatation C... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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 238
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K223177.
D·Kaptain PTA High Pressure Balloon Dilatation Catheter
K214009 · Dk Medical Technology Co., Ltd. · Apr 2023
Arise™ UHP Dilatation Catheter
K230191 · Creagh Medical, Ltd. · Mar 2023
Passeo-35 Xeo Peripheral Dilatation Catheter
K222065 · Biotronik, Inc. · Feb 2023
PTA Balloon Dilatation Catheter
K221245 · Kossel Medtech (Suzhou) Co., Ltd. · Dec 2022
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
K221414 · Silk Road Medical, Inc. · Sep 2022
SABER .014 PTA Dilatation Catheter
K221832 · Cordis US Corp · Aug 2022