510(k) · Cleared
ClearedVia Microcatheter, Via Plus Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sequent Medical, Inc. · KRA Catheter, Continuous Flush
Cleared on Mar 19, 2013 as substantially equivalent to K091559 (Chestnut Medical Technologies, Inc., 2009) and 1 other predicate after a 126-day review. Its family tree reaches back 5 generations to 1996. 4 later devices descend from it.
- Decided
- Mar 19, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K960806 (1996). 8 ancestors in all, the oldest K925813 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 4 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 3 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 2 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
- 1 generation backK113778 Excelsior XT-27 MicrocatheterStryker Neurovascular · 2012 · Recalled
- This deviceK123477 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK132652 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK162565 VIA 17 MicrocatheterSequent Medical, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK192135 VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA…MicroVention, Inc. · 2019 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · cites it directly3descendants
- K150894VIA 21 MicrocatheterSequent Medical, Inc. · 2015 · 2 generations on2descendants
- K162565VIA 17 MicrocatheterSequent Medical, Inc. · 2017 · 2 generations on1descendant
- K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −4 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −3 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −2 | K042568 | Excelsior 1018 and SL-10 Microcatheters | Boston Scientific Corp | 2004 | 7 |
| −1 | K113778 | Excelsior XT-27 Microcatheter | Stryker Neurovascular | 2012 | 3 |
| 0 (this device) | K123477 | Via Microcatheter, Via Plus Microcatheter | Sequent Medical, Inc. | 2013 | — |
| +1 | K132652 | Via Microcatheter, Via Plus Microcatheter | Sequent Medical, Inc. | 2013 | 1 |
| +2 | K150894 | VIA 21 Microcatheter | Sequent Medical, Inc. | 2015 | — |
| +2 | K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | 2017 | — |
| +2 | K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter… | MicroVention, Inc. | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 14.4 · 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? (2)
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 |
|---|---|---|---|
| * | K091559 | Marksmann CatheterSummary page 1…ASSIFICATION PRODUCT CODES DQY: Percutaneous Catheter KRA: Continuous Flush Catheter PREDICATE Marksman Catheter (K09 1559) DEVICES Excelsior XT-27 Microcatheter (Ki 13778) SUBSTANTIALLY EQUIVALENT To: The VIATM Microcatheter is sub… | 2009 |
| * | K113778 | Excelsior XT-27 Microcatheter | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132652 | Via Microcatheter, Via Plus Microcatheter | 2013 | 3 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K132652 (Sequent Medical, Inc., 2013) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K091559.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 VIATM Microcatheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral and coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123477: Via Microcatheter, Via Plus Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123477
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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