# 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 - Pathway: 510(k) (Special) - Applicant: Abbott Vascular - Decided: Aug 24, 2018 after 231 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 Longest line of descent: 1 generation back to K103153 (2010). 7 ancestors in all. 2 later devices descend from it; 2 cite it directly. 2 of 10 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K103153: Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation Catheter, Abbott Vascular-Cardiac Therapies (2010) Summary page 5. - K110134: NC Trek RX Coronary Dilatation Catheter, Abbott Vascular-Cardiac Therapies (2011) Summary page 5. - K113464: NC Trek Otw Coronary Dilatation Catheter, Abbott Vascular (2012) Summary page 5. - K103110: Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and Trek (TM) Otw Dilatation Catheter, Abbott Vascular-Cardiac Therapies (2011) Summary page 5. - K110617: Mini Trek RX 1.20 MM Coronary Dilatation Catheter, Mini Trek Otw 1.20 MM Coronary Dilatation Catheter, Abbott Vascular (2011). Our reading of the summary gave K110671, FDA’s number for Winco Stretchair (Winco Mfg., LLC). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “TREK™ RX Coronary Dilatation Catheter”. - K123279: Mini Trek RX Coronary Dilatation Catheter (Including 1.20 MM Size), Mini Trek Otw Coronary Dilatation Catheter (Includin, Abbott Vascular (2013) Summary page 5. - K121222: Trek Otw Coronary Dilatation Catheter Mini Trek Otw Coronary Dilatation Catheter, Abbott Vascular (2012) Summary page 5. ## Most influential descendants - 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 RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm – 5.0 mm only). The NC TREK OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm – 5.00 mm only) The TREK RX 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 perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation. The TREK OTW and MINI TREK OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm –5.00 mm only). The MINI TREK RX 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 perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); d) Balloon dilatation of de novo chronic total coronary occlusions (CTO). The MINI TREK II OTW Coronary Dilatation Catheter is indicated for: a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion; b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction (MI); c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); d) Balloon dilatation of de novo chronic total coronary occlusions (CTO). Source page: https://510kreport.com/device/K180040 Methodology: https://510kreport.com/methodology