510(k) · Cleared
ClearedMaverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
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 Dec 14, 2016 as substantially equivalent to P860019 (Scimed Life Systems, Inc., 1986) after a 29-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Dec 14, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- LOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P860019 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backP860019 Scimed Ptca Dilatation CatheterScimed Life Systems, Inc. · 1986 · Recalled
- This deviceK163200 Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail…Boston Scientific Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P860019 | Scimed Ptca Dilatation Catheter | Scimed Life Systems, Inc. | 1986 | 5 |
| 0 (this device) | K163200 | Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation… | Boston Scientific Corporation | 2016 | — |
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 |
|---|---|---|---|
| * | P860019 | Scimed Ptca Dilatation CatheterSummary page 4…Facilities: Coventry, RI 02816 USA Predicate Devices P860019 - Maverick™ XL Percutaneous Transluminal Coronary Angioplasty Monorail™ Dilatation Catheter, date reclass… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 20 other devices also cite its predicate P860019.
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. 2016, 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 Maverick XL balloon catheter is indicated for balloon dilatation of the
stenotic portion of a coronary artery or bypass graft for the purpose of improving
myocardial perfusion. The Maverick XL balloon catheter is also indicated for the
post delivery expansion of balloon expandable stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163200 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163200: Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163200
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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