510(k) · Cleared
ClearedTRUSELECT 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 Jul 28, 2020 as substantially equivalent to K163701 (Boston Scientific Corporation, 2017) after a 28-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Jul 28, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000177 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK000177 Renegade HI-Flo MicrocatheterBoston Scientific Corp · 2000 · Recalled
- 4 generations backK100892 Renegade HI-Flo Fathom Kit Model M001182XXXBoston Scientific Corp · 2010
- 3 generations backK132947 Direxion and Direxion HI-Flo Torqueable MicrocathetersBoston Scientific Corp · 2013
- 2 generations backK142259 Direxion Torqueable MicrocatheterBoston Scientific Corp · 2014
- 1 generation backK163701 Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation · 2017 · Recalled
- This deviceK201792 TRUSELECT MicrocatheterBoston Scientific Corporation · 2020
- Descendant · cites it directly · 0 of its ownK260771 TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026
Most influential descendants
Showing 1 of 1 · See all- K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000177 | Renegade HI-Flo Microcatheter | Boston Scientific Corp | 2000 | 5 |
| −4 | K100892 | Renegade HI-Flo Fathom Kit Model M001182XXX | Boston Scientific Corp | 2010 | — |
| −3 | K132947 | Direxion and Direxion HI-Flo Torqueable Microcatheters | Boston Scientific Corp | 2013 | — |
| −2 | K142259 | Direxion Torqueable Microcatheter | Boston Scientific Corp | 2014 | — |
| −1 | K163701 | Direxion and Direxion HI-FLO Torqueable Microcatheters | Boston Scientific Corporation | 2017 | 41 |
| 0 (this device) | K201792 | TRUSELECT Microcatheter | Boston Scientific Corporation | 2020 | — |
| +1 | K260771 | TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K163701 | Direxion and Direxion HI-FLO Torqueable MicrocathetersSummary page 5…Catheter Catheter III. PREDICATE DEVICE IDENTIFICATION Name of Predicate Device Direxion™ Microcatheter, K163701 Predicate devices referenced above have not been subject to a design-related recall. IV. DEVICE DESCRIPTION The TRUSELEC… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260771 | TruSelect™ 2.6 Microcatheter | 2026 | 0 |
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 20 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K260771 (Boston Scientific Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K163701.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 TRUSELECTTM Microcatheters are intended for peripheral vascular use. The microcatheter can be used for
selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201792 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201792: TRUSELECT Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201792
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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