# K123279: Mini Trek RX Coronary Dilatation Catheter (Including 1.20 MM Size), Mini Trek Otw Coronary Dilatation Catheter (Includin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular
- Decided: Jan 30, 2013 after 100 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) MINI TREK RX 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

## 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 MINI TREK RX, MINI TREK OTW and MINI TREK 11 OTW Coronary Dilatation Catheters (balloon models 1.50 mm - 2.00 mm) are 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 infarction Balloon dilatation of a stent after implantation (balloon models 2.00 mm only) Balloon dilatation of de novo chronic total coronary occlusions (CTO) The MINI TREK RX, MINI TREK OTW and MINI TREK 11 OTW Coronary Dilatation Catheters (balloon models 1.20 mm) are indicated for: Initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) Balloon dilatation of de novo chronic total coronary occlusions (CTO)

Source page: https://510kreport.com/device/K123279
Methodology: https://510kreport.com/methodology