510(k) · Cleared
ClearedTruSelect™ 2.6 Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · KRA Catheter, Continuous Flush
Cleared on May 15, 2026 as substantially equivalent to K201792 (Boston Scientific Corporation, 2020) after a 67-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- May 15, 2026
- Review
- 67 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000177 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK000177 Renegade HI-Flo MicrocatheterBoston Scientific Corp · 2000 · Recalled
- 5 generations backK100892 Renegade HI-Flo Fathom Kit Model M001182XXXBoston Scientific Corp · 2010
- 4 generations backK132947 Direxion and Direxion HI-Flo Torqueable MicrocathetersBoston Scientific Corp · 2013
- 3 generations backK142259 Direxion Torqueable MicrocatheterBoston Scientific Corp · 2014
- 2 generations backK163701 Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation · 2017 · Recalled
- 1 generation backK201792 TRUSELECT MicrocatheterBoston Scientific Corporation · 2020
- This deviceK260771 TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000177 | Renegade HI-Flo Microcatheter | Boston Scientific Corp | 2000 | 5 |
| −5 | K100892 | Renegade HI-Flo Fathom Kit Model M001182XXX | Boston Scientific Corp | 2010 | — |
| −4 | K132947 | Direxion and Direxion HI-Flo Torqueable Microcatheters | Boston Scientific Corp | 2013 | — |
| −3 | K142259 | Direxion Torqueable Microcatheter | Boston Scientific Corp | 2014 | — |
| −2 | K163701 | Direxion and Direxion HI-FLO Torqueable Microcatheters | Boston Scientific Corporation | 2017 | 41 |
| −1 | K201792 | TRUSELECT Microcatheter | Boston Scientific Corporation | 2020 | — |
| 0 (this device) | K260771 | TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | 2026 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K201792 | TRUSELECT MicrocatheterSummary page 5…ter Catheter III. PREDICATE DEVICE IDENTIFICATION Predicate Device TruSelect™ Microcatheter (K201792, cleared on July 28, 2020), Boston Scientific Corporation… | 2020 |
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?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 TruSelect 2.6 Microcatheter is intended to provide a conduit for the selective infusion of diagnostic, embolic, or therapeutic agents to target vessels within the peripheral vasculature during endovascular procedures. The microcatheter is coaxially tracked over a steerable guidewire to access the distal peripheral vasculature. Diagnostic, embolic, or therapeutic agents should be used in accordance with specifications outlined by the manufacturer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260771 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260771: TruSelect™ 2.6 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260771
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026