510(k) · Cleared
Recalled · Class II · 2019Euphora Rapid Exchange Balloon Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Cleared on Apr 2, 2015 as substantially equivalent to P790017 (Medtronic, Ireland, 1980) after a 115-day review. Its family tree reaches back 1 generation to 1980. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 2, 2015
- Review
- 115 days
- Class
- Class II
- Product code
- LOX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to P790017 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP790017 Usci Dilatation CatheterMedtronic, Ireland · 1980
- This deviceK143480 Euphora Rapid Exchange Balloon Dilatation CatheterMedtronic, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK163372 RX Takeru Balloon Dilatation CatheterKANEKA Corporation · 2017
- Descendant · cites it directly · 0 of its ownK261759 Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic Ireland · 2026
- Descendant · 2 generations on · 0 of its ownK172264 OTW Takeru PTCA Balloon Dilatation CatheterKANEKA Corporation · 2018
Most influential descendants
Showing 3 of 3 · See all- K163372RX Takeru Balloon Dilatation CatheterKANEKA Corporation · 2017 · cites it directly1descendant
- K261759Euphora Rapid Exchange (RX) Balloon Dilatation CatheterMedtronic Ireland · 2026 · cites it directly0descendants
- K172264OTW Takeru PTCA Balloon Dilatation CatheterKANEKA Corporation · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P790017 | Usci Dilatation Catheter | Medtronic, Ireland | 1980 | — |
| 0 (this device) | K143480 | Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic, Inc. | 2015 | — |
| +1 | K163372 | RX Takeru Balloon Dilatation Catheter | KANEKA Corporation | 2017 | — |
| +1 | K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland | 2026 | — |
| +2 | K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | KANEKA Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 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.
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? (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 |
|---|---|---|---|
| * | P790017 | Usci Dilatation CatheterSummary page 6…redicate device with respect to intended use, design and technology: Device: Medtronic Sprinter Legend® RX Balloon Dilatation Catheter (P790017/S096, approved October 31, 2008) This predicate has not been subject to a design-related recall. Reference… | 1980 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Sep 3, 2019 | Class II | Z-0122-2020 | Under Investigation by firm | Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties. |
| Jul 13, 2017 | Class II | Z-3137-2017 | Process design | Stylette removal difficulties on the Euphora and Solarice products. |
| Jul 13, 2017 | Class II | Z-3136-2017 | Process design | Stylette removal difficulties on the Euphora and Solarice products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2015, 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 Euphora™ RX Balloon Dilatation 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. The balloon dilatation catheter (balloon models 2.00mm to 4.00mm) is also indicated for post deployment expansion of balloon expandable stents.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143480: Euphora Rapid Exchange Balloon 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/K143480
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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