510(k) · Cleared
Recalled · Class II · 2019NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter (Over-the-Wire)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Aug 7, 2014 as substantially equivalent to K113220 (Boston Scientific Corporation, 2012) and 2 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1986. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 7, 2014
- Review
- 86 days
- Class
- Class II
- Product code
- LOX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to P860019 (1986). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- 1 generation backK113220 Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation…Boston Scientific Corporation · 2012 · Recalled
- This deviceK141236 NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca…Boston Scientific Corporation · 2014
- Descendant · cites it directly · 0 of its ownK223189 Firefighter™ NC Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK222538 NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK211393 Selethru (TM) NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K223189Firefighter™ NC Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd. · 2023 · cites it directly0descendants
- K222538NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc. · 2022 · cites it directly0descendants
- K211393Selethru (TM) NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2021 · 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 | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter… | Boston Scientific Corporation | 2012 | 1 |
| 0 (this device) | K141236 | NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation… | Boston Scientific Corporation | 2014 | — |
| +1 | K223189 | Firefighter™ NC Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2023 | — |
| +1 | K222538 | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2022 | — |
| +1 | K211393 | Selethru (TM) NC PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
Planning a device in LOX? 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? (3)
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 |
|---|---|---|---|
| * | K113220 | Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)Summary page 4…asty (PTCA) Dilatation Catheter Product Code LOX Classification Class II, 21 CFR Part 870.5100 Predicate Emerge PTCA K113220 22 March 2012 Devices Dilatation Catheter (2.00 – 4.00 mm diameter M… | 2012 |
| * | K121667 | NC Quantum Apex Ptca Dilatation Catheter (Monorail)Summary page 4…2.00 – 4.00 mm diameter Monorail and Over-the-Wire balloon models) NC Quantum Apex™ K121667 18 August 2012 PTCA Dilatation Catheter (Monorail) NC Quantu… | 2012 |
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 4…K121667 18 August 2012 PTCA Dilatation Catheter (Monorail) NC Quantum Apex™ P860019/S241 16 April 2010 PTCA Dilatation Catheter (Prior to (Over-the-Wire)… | 1986 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2019 | Class II | Z-0579-2020 | Process control | Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 25.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K223189 (Shanghai MicroPort Medical (Group) Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K113220.
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. 2014, 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 Emerge Over-The-Wire (OTW) and NC Emerge Monorail (MR) PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis.
NC Emerge Over-The-Wire and NC Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141236: NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter (Over-the-Wire).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141236
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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