# K113464: NC Trek Otw Coronary Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular
- Decided: Mar 6, 2012 after 105 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) NC TREK RX Coronary Dilatation Catheter: named in the summary without a submission number
- (no number) TREK OTW Coronary Dilatation Catheter: named in the summary without a submission number
- (no number) MINI TREK OTW Coronary Dilatation Catheter: named in the summary without a submission number
- (no number) VOYAGER NC Coronary Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K180040: NC TREK™ RX Coronary Dilatation Catheter; 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 (2018), 2 descendants of its own
- K252116: Firefighter™ Pro PTCA Balloon Catheter (2026), 0 descendants of its own
- K220634: NC TREK NEO Coronary Dilatation Catheter (2022), 0 descendants of its own

## Indications for use
The NC TREK™ OTW Coronary Dilatation Catheter is indicated for: * balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; * balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarctions; & balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

Source page: https://510kreport.com/device/K113464
Methodology: https://510kreport.com/methodology