# K103110: Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and Trek (TM) Otw Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular-Cardiac Therapies
- Decided: Jan 10, 2011 after 94 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 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) VOYAGER® RX 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
- (no number) VOYAGER® OTW Coronary Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K112735: Tamarin Blue Ptca RX Dilatation Catheter (2012), 5 descendants of its own
- 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
- K131169: Mozec - RX Ptca Balloon Dilatation Catheter (2013), 2 descendants of its own
- K160961: Mozec NC-Rx PTCA Baloon Dilatation Catheter (2016), 1 descendant of its own
- K252116: Firefighter™ Pro PTCA Balloon Catheter (2026), 0 descendants of its own

## Indications for use
The TREKTNI RX, MINI TREKTMl RX, TREKTNIOTW, and MINI TREKTM OTW Coronary Dilatation Catheters are indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perforusion; b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segement elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

Source page: https://510kreport.com/device/K103110
Methodology: https://510kreport.com/methodology