510(k) · Cleared
Recalled · Class I · 2020Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Vascular-Cardiac Therapies · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Dec 30, 2010 after a 77-day review. The FDA summary names its predicate without a number. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 20 times, including 20 Class I recalls.
- Decided
- Dec 30, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- LOX
- Recalls
- 20 (20 Class I)
- Predicates
- 0
5 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK103153 Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary…Abbott Vascular-Cardiac Therapies · 2010
- Descendant · cites it directly · 2 of its ownK180040 NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary…Abbott Vascular · 2018
- Descendant · cites it directly · 1 of its ownK160961 Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited · 2016
- Descendant · 2 generations on · 0 of its ownK252116 Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK220634 NC TREK NEO Coronary Dilatation CatheterAbbott Vascular · 2022
- Descendant · 2 generations on · 0 of its ownK181023 Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA…Meril Life Sciences Private Limited · 2018
Most influential descendants
Showing 5 of 5 · See all- K180040NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter…Abbott Vascular · 2018 · cites it directly2descendants
- K160961Mozec NC-Rx PTCA Baloon Dilatation CatheterMeril Life Sciences Private Limited · 2016 · cites it directly1descendant
- K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2026 · 2 generations on0descendants
- K220634NC TREK NEO Coronary Dilatation CatheterAbbott Vascular · 2022 · 2 generations on0descendants
- K181023Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation…Meril Life Sciences Private Limited · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K103153 | Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation… | Abbott Vascular-Cardiac Therapies | 2010 | — |
| +1 | K180040 | NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation… | Abbott Vascular | 2018 | — |
| +1 | K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | Meril Life Sciences Private Limited | 2016 | — |
| +2 | K252116 | Firefighter™ Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026 | — |
| +2 | K220634 | NC TREK NEO Coronary Dilatation Catheter | Abbott Vascular | 2022 | — |
| +2 | K181023 | Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon… | Meril Life Sciences Private Limited | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LOX device
- #1 K254022 FLASH Flex™ Aorto-Ostial Angioplasty Systemscore 12.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | VOYAGER® NC Coronary Dilatation Catheter Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2020 | Class I | Z-1136-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1131-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1130-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1133-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1135-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1128-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1134-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1143-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1129-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1142-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1140-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1144-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1132-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1138-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1139-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1141-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Jan 29, 2020 | Class I | Z-1137-2020 | Process change control | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. |
| Mar 22, 2017 | Class I | Z-2039-2017 | Device Design | 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 | Device Design | 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 | Device Design | 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. |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K180040 (Abbott Vascular, 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LOX devicesLOX Catheters, Transluminal Coronary Angioplasty, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LOX
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LOX
241in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOX
4in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOX
1,890in 2025
MAUDE reports naming product code LOX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 19 | — | 1 | 1,053 |
| 2008 | 22 | — | 80 | 1,063 |
| 2009 | 28 | — | 0 | 1,353 |
| 2010 | 32 | — | 0 | 1,392 |
| 2011 | 9 | 103 | 0 | 2,090 |
| 2012 | 10 | 120 | 0 | 2,092 |
| 2013 | 6 | 123 | 0 | 2,436 |
| 2014 | 6 | 166 | 0 | 2,316 |
| 2015 | 4 | 119 | 0 | 2,060 |
| 2016 | 9 | 116 | 0 | 2,578 |
| 2017 | 6 | 113 | 0 | 2,753 |
| 2018 | 7 | 80 | 0 | 2,225 |
| 2019 | 1 | — | 4 | 2,102 |
| 2020 | 1 | — | 0 | 1,974 |
| 2021 | 6 | 167 | 0 | 1,738 |
| 2022 | 5 | 121 | 0 | 1,816 |
| 2023 | 4 | 138 | 0 | 1,720 |
| 2024 | 4 | 241 | 0 | 1,804 |
| 2025 | 0 | — | 0 | 1,890 |
| 2026 | 6 | 156 | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103153: Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103153
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026