Cleared Special

K110134 - NC TREK RX CORONARY DILATATION CATHETER

K110134 is an FDA 510(k) clearance for NC TREK RX CORONARY DILATATION CATHETER, manufactured by Abbott Vascular-Cardiac Therapies. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Special 510(k) pathway after a 24-day FDA review.

K110134 · Abbott Vascular-Cardiac Therapies · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
24d
Days
Class 2
Risk

K110134 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-Cardiac Therapies (Temecula, US). The FDA issued a Cleared decision on February 11, 2011 after a review of 24 days - a notably fast clearance 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. 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.

FDA 510(k) Submission Details - K110134

510(k) Number K110134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2011
Decision Date February 11, 2011
Days to Decision 24 days
Submission Type Special
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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

LOX Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K110134.
SAPPHIRE
K103657 · Orbusneich Medical, Inc. · Aug 2011
EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
K110133 · Creganna-Tactx Medical · Jun 2011
MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
K110617 · Abbott Vascular · Jun 2011
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER
K103110 · Abbott Vascular-Cardiac Therapies · Jan 2011
VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
K103153 · Abbott Vascular-Cardiac Therapies · Dec 2010
SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON
K103095 · Medtronic, Ireland · Oct 2010
K110134 · NC TREK RX CORONARY DILATATION CATHETER
Download PDF FDA Summary Abbott Vascular-Cardi…