510(k) · Cleared
Recalled · Class II · 2026Direxion and Direxion HI-FLO Torqueable Microcatheters
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 16, 2017 as substantially equivalent to K142259 (Boston Scientific Corp, 2014) after a 138-day review. Its family tree reaches back 4 generations to 2000. 3 later devices descend from it. It has been recalled 41 times.
- Decided
- May 16, 2017
- Review
- 138 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 41
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000177 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000177 Renegade HI-Flo MicrocatheterBoston Scientific Corp · 2000 · Recalled
- 3 generations backK100892 Renegade HI-Flo Fathom Kit Model M001182XXXBoston Scientific Corp · 2010
- 2 generations backK132947 Direxion and Direxion HI-Flo Torqueable MicrocathetersBoston Scientific Corp · 2013
- 1 generation backK142259 Direxion Torqueable MicrocatheterBoston Scientific Corp · 2014
- This deviceK163701 Direxion and Direxion HI-FLO Torqueable MicrocathetersBoston Scientific Corporation · 2017
- Descendant · cites it directly · 1 of its ownK201792 TRUSELECT MicrocatheterBoston Scientific Corporation · 2020
- Descendant · 2 generations on · 0 of its ownK260771 TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026
- Descendant · cites it directly · 0 of its ownK231821 XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S…Transit Scientific, LLC · 2023
Most influential descendants
Showing 3 of 3 · See all- K201792TRUSELECT MicrocatheterBoston Scientific Corporation · 2020 · cites it directly1descendant
- K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026 · 2 generations on0descendants
- K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…Transit Scientific, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000177 | Renegade HI-Flo Microcatheter | Boston Scientific Corp | 2000 | 5 |
| −3 | K100892 | Renegade HI-Flo Fathom Kit Model M001182XXX | Boston Scientific Corp | 2010 | — |
| −2 | K132947 | Direxion and Direxion HI-Flo Torqueable Microcatheters | Boston Scientific Corp | 2013 | — |
| −1 | K142259 | Direxion Torqueable Microcatheter | Boston Scientific Corp | 2014 | — |
| 0 (this device) | K163701 | Direxion and Direxion HI-FLO Torqueable Microcatheters | Boston Scientific Corporation | 2017 | — |
| +1 | K201792 | TRUSELECT Microcatheter | Boston Scientific Corporation | 2020 | — |
| +2 | K260771 | TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | 2026 | — |
| +1 | K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S… | Transit Scientific, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K142259 | Direxion Torqueable MicrocatheterSummary page 4…Catheters Classification Class II per CFR 870.1210 Predicate Device Boston Scientific Direxion Microcatheters: • K142259, KRA, September 10, 2014 ___________________________________________________________________________________ Page 1 of 3… | 2014 |
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 16, 2026 | Class II | Z-0224-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0249-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0232-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0255-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0227-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0245-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0258-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0259-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0231-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0250-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0229-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0260-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0263-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0243-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0241-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0226-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0251-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0248-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0262-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0234-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0254-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0230-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0252-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0246-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0253-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0261-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0247-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0225-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0237-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0242-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0238-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0228-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0233-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0244-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0240-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0256-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0236-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0239-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0223-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0235-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
| Sep 16, 2026 | Class II | Z-0257-2027 | Process control | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. |
The 5 latest of 41 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K201792 (Boston Scientific Corporation, 2020) has gone furthest, with 1 descendant 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. 2017, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2007high 8 (2016) · low 0 (2015)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
2007high 268 (2026) · low 29 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
2007high 41 (2026) · low 0 (2017)2026
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
2007high 980 (2025) · low 117 (2008)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 Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
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/K163701 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163701: Direxion and Direxion HI-FLO Torqueable Microcatheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163701
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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