Cleared Traditional

K110617 - MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER

K110617 is an FDA 510(k) clearance for MINI TREK RX 1.20 MM CORONARY DILATATIO..., manufactured by Abbott Vascular. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K110617 · Abbott Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
91d
Days
Class 2
Risk

K110617 is an FDA 510(k) clearance for the MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORO.... Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Abbott Vascular (Temecula, US). The FDA issued a Cleared decision on June 2, 2011 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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 Abbott Vascular devices

FDA 510(k) Submission Details - K110617

510(k) Number K110617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date June 02, 2011
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01186198 Completed Observational Industry-sponsored

A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions

71
Patients (actual)
4
Sites
Condition studied Ischemic Heart Disease; Coronary Artery Stenosis; Chronic Coronary Total Occlusion; Coronary Bypass Graft Stenosis
Eligibility All sexes · 18 Years+
Principal investigator David E Kandzari, MD
Sponsor Abbott Medical Devices (industry)
Started 2010-08-12 → Primary completion 2010-12-30
Primary outcome
Percentage of Participants With Procedure Success
Secondary outcome
Rate of Device Success
View full study on ClinicalTrials.gov

Regulatory Peers - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 83
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K110617.
FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
K111284 · Ostial Corporation · Aug 2011
SAPPHIRE
K103657 · Orbusneich Medical, Inc. · Aug 2011
EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
K110133 · Creganna-Tactx Medical · Jun 2011
NC TREK RX CORONARY DILATATION CATHETER
K110134 · Abbott Vascular-Cardiac Therapies · Feb 2011
THE PILOT SCIMED TORQUE DEVICE
K896108 · Scimed Life Systems, Inc. · Jan 1990
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
K861847 · Advanced Cardiovascular Systems, Inc. · Jun 1986