Cleared Special

K180040 - NC TREK™ RX Coronary Dilatation Catheter (FDA 510(k) Clearance)

Also includes:
NC TREK™ OTW Coronary Dilatation Catheter TREK™ RX Coronary Dilatation Catheter TREK™ OTW Coronary Dilatation Catheter MINI TREK™ RX Coronary Dilatation Catheter MINI TREK™ OTW Coronary Dilatation Catheter MINI TREK™ II OTW Coronary Dilatation Catheter

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180040 · Abbott Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
231d
Days
Class 2
Risk

K180040 is an FDA 510(k) clearance for the NC TREK™ RX Coronary Dilatation Catheter. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Abbott Vascular (Santa Clara, US). The FDA issued a Cleared decision on August 24, 2018 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Vascular devices

Submission Details

510(k) Number K180040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2018
Decision Date August 24, 2018
Days to Decision 231 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
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 85
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K180040.
Firefighter™ Pro PTCA Balloon Catheter
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FLASH Flex™ Aorto-Ostial Angioplasty System
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Ryurei
K252295 · Terumo Corporation · Mar 2026
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
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Pantera Pro
K242969 · Biotronik, Inc. · Oct 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
K233499 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Aug 2024