# K103153: Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular-Cardiac Therapies
- Decided: Dec 30, 2010 after 77 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: 20 (20 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has 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® 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
- 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
- K220634: NC TREK NEO Coronary Dilatation Catheter (2022), 0 descendants of its own
- K181023: Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter (2018), 0 descendants of its own

## Recalls of this device
- Jan 29, 2020 · Class I · Z-1136-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1131-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1130-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1133-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1135-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1128-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1134-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1143-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1129-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1142-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1140-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1144-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1132-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1138-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1139-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1141-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Jan 29, 2020 · Class I · Z-1137-2020: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Mar 22, 2017 · Class I · Z-2039-2017: Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
- Mar 22, 2017 · Class I · Z-2037-2017: Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
- Mar 22, 2017 · Class I · Z-2038-2017: Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

## Indications for use
The NC TREKTM 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).

Source page: https://510kreport.com/device/K103153
Methodology: https://510kreport.com/methodology