510(k) · Cleared
ClearedNC Gallant PTCA Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medinol, Ltd. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Jan 19, 2017 as substantially equivalent to K110134 (Abbott Vascular-Cardiac Therapies, 2011) and 1 other predicate after a 141-day review. Its family tree reaches back 2 generations to 1986. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jan 19, 2017
- Review
- 141 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P860019 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 1 generation backK121667 NC Quantum Apex Ptca Dilatation Catheter (Monorail)Boston Scientific Corp · 2012
- This deviceK162434 NC Gallant PTCA CatheterMedinol, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK173581 Gallant PTCA Dilatation CatheterMedinol, Ltd. · 2018
Class I recalls in this family
- K110134 NC Trek RX Coronary Dilatation Catheterdirect predicate · 2011
Most influential descendants
Showing 1 of 1 · See all- K173581Gallant PTCA Dilatation CatheterMedinol, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| −1 | K121667 | NC Quantum Apex Ptca Dilatation Catheter (Monorail) | Boston Scientific Corp | 2012 | — |
| 0 (this device) | K162434 | NC Gallant PTCA Catheter | Medinol, Ltd. | 2017 | — |
| +1 | K173581 | Gallant PTCA Dilatation Catheter | Medinol, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K110134 | NC Trek RX Coronary Dilatation CatheterSummary page 4…angioplasty, percutaneous Name Product Code LOX Classification Class II, 21 CFR Part 870.5100 Predicate NC Trek, Abbott (K110134) Devices NC Quantum, Boston Scientific (K121667) Device The NC Gallant is a sterile, sin… | 2011 |
| * | K121667 | NC Quantum Apex Ptca Dilatation Catheter (Monorail)Summary page 4…Classification Class II, 21 CFR Part 870.5100 Predicate NC Trek, Abbott (K110134) Devices NC Quantum, Boston Scientific (K121667) Device The NC Gallant is a sterile, single-use, intravascular medical device. Description T… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173581 | Gallant PTCA Dilatation Catheter | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K110134NC Trek RX Coronary Dilatation CatheterAbbott Vascular-Cardiac Therapies · 2011 · Direct predicate · ◆ in the 2011 ancestors bar of FIG. 117 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 25.7 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K173581 (Medinol, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K110134.
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. 2017, 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 Gallant PTCA Catheter is indicated for:
• Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
• Post-deployment stent expansion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162434: NC Gallant PTCA Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162434
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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