510(k) Report

510(k) · Cleared

Cleared

Via Microcatheter, Via Plus Microcatheter

K123477510(k) TraditionalCleared Mar 19, 2013126-day reviewClass II21 CFR 870.1210

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2000: 1 other ancestor1994: 1 other ancestor2013: 1 descendant cleared2019: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant clearedK960806 · Turbo Tracker · Target Therapeutics · 1996K994155 · Excelsior 1018 Microcatheter · Boston Scientific, Target · 2000K013789 · Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 · Boston Scientific, Target · 2001 · recalledK042568 · Excelsior 1018 and SL-10 Microcatheters · Boston Scientific Corp · 2004 · recalledK113778 · Excelsior XT-27 Microcatheter · Stryker Neurovascular · 2012 · recalled1990200020102020
  1. Root · 5 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
  2. 4 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
  3. 3 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
  4. 2 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
  5. 1 generation backK113778 Excelsior XT-27 MicrocatheterStryker Neurovascular · 2012 · Recalled
  6. This deviceK123477 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013
  7. Descendant · cites it directly · 3 of its ownK132652 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · Recalled
  8. Descendant · 2 generations on · 2 of its ownK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
  9. Descendant · 2 generations on · 1 of its ownK162565 VIA 17 MicrocatheterSequent Medical, Inc. · 2017
  10. 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

GenerationNumberDeviceApplicantDecidedRecalls
−5K960806Turbo TrackerTarget Therapeutics1996—
−4K994155Excelsior 1018 MicrocatheterBoston Scientific, Target2000—
−3K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target20012
−2K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp20047
−1K113778Excelsior XT-27 MicrocatheterStryker Neurovascular20123
0 (this device)K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.2013—
+1K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20131
+2K150894VIA 21 MicrocatheterSequent Medical, Inc.2015—
+2K162565VIA 17 MicrocatheterSequent Medical, Inc.2017—
+2K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter…MicroVention, Inc.20193

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200010
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201710
201910
FIG. 1 — Lineage of K123477, 1996–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K091559Marksmann Catheter
Summary 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…
Chestnut Medical Technologies, Inc.2009—
*K113778Excelsior XT-27 MicrocatheterStryker Neurovascular20123

Also cleared against K091559: 4 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20133

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 devices

KRA 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

2007: 52008: 72009: 52010: 22011: 22012: 32013: 32014: 42016: 82017: 42018: 42019: 42020: 62021: 62022: 62023: 72025: 12026 (partial year): 5
2007high 8 (2016) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRA

63in 2023

2007: 44 days median2008: 144 days median2009: 69 days median2012: 29 days median2013: 126 days median2014: 61 days median2016: 122 days median2017: 166 days median2018: 178 days median2019: 133 days median2020: 29 days median2021: 108 days median2022: 228 days median2023: 63 days median2026 (partial year): 268 days median
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

2007: 22008: 62009: 82010: 262011: 32012: 32013: 22014: 3, 2 Class I2015: 12016: 3, 1 Class I2019: 4, 4 Class I2020: 12023: 22026 (partial year): 41
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

2007: 1182008: 1172009: 1872010: 3552011: 2392012: 2172013: 2092014: 2762015: 3392016: 4182017: 5382018: 4342019: 4182020: 3812021: 4402022: 5432023: 8292024: 9422025: 980
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075442118
200871446117
20095698187
20102—26355
20112—3239
20123293217
201331262209
20144613 (2)276
20150—1339
201681223 (1)418
201741660538
201841780434
201941334 (4)418
20206291381
202161080440
202262280543
20237632829
20240—0942
20251—0980
2026526841—

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.

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