K123279 is an FDA 510(k) clearance for the MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK.... 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 January 30, 2013 after a review of 100 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.
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NCT01435031
Completed
Interventional
Industry-sponsored
EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
| Condition studied |
Coronary Artery Disease (CAD); Chronic Total Occlusion (CTO) |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
David E. Kandzari, MD |
| Sponsor |
Abbott Medical Devices
(industry)
|
Started 2011-09-01
→
Primary completion 2014-02-01
→
Completed 2017-12-01
Primary outcome
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)
Secondary outcome
Minimum Lumen Diameter (MLD): Pre-procedure
View full study on ClinicalTrials.gov