510(k) · Cleared
ClearedMarksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled Lengths and Distal Shaft Lengths
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · KRA Catheter, Continuous Flush
Cleared on Sep 16, 2011 after a 108-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Sep 16, 2011
- Review
- 108 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK111490 Marksman Catheter, *Refers to Different Catheter Working Lenghts…Ev3, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK152625 MMS Guide CatheterMicro Medical Solutions, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK163231 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK170406 Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK170635 Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK143398 Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K152625MMS Guide CatheterMicro Medical Solutions, Inc. · 2016 · cites it directly2descendants
- K163231Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017 · 2 generations on1descendant
- K170406Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC · 2017 · cites it directly0descendants
- K170635Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd. · 2017 · 3 generations on0descendants
- K143398Plato MICROCATH 27B MicrocatheterScientia Vascular, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111490 | Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal… | Ev3, Inc. | 2011 | — |
| +1 | K152625 | MMS Guide Catheter | Micro Medical Solutions, Inc. | 2016 | — |
| +2 | K163231 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017 | 2 |
| +1 | K170406 | Plato MICROCATH 27B Microcatheter | Scientia Vascular, LLC | 2017 | — |
| +3 | K170635 | Chameleon PTA Balloon Catheter | Av Medical Technologies, Ltd. | 2017 | — |
| +1 | K143398 | Plato MICROCATH 27B Microcatheter | Scientia Vascular, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 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 KRA? 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.5 · 9 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.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K152625 (Micro Medical Solutions, Inc., 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The MarksmanTM Catheter is indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the neuro, peripheral and coronary vasculature.
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/K111490 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111490: Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled Lengths and Distal Shaft Lengths.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111490
Report an extraction error
Are you the manufacturer?
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