510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Via Microcatheter, Via Plus Microcatheter

K132652510(k) TraditionalCleared Dec 20, 2013116-day reviewClass II21 CFR 870.1250Recalls 1

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

Sequent Medical, Inc. · DQY Catheter, Percutaneous

Cleared on Dec 20, 2013 as substantially equivalent to K091559 (Chestnut Medical Technologies, Inc., 2009) and 2 other predicates after a 116-day review. Its family tree reaches back 6 generations to 1996. 3 later devices descend from it. It has been recalled once.

Decided
Dec 20, 2013
Review
116 days
Class
Class II
Product code
DQY
Recalls
1
Predicates
3

Its longest line of descent runs back 6 generations to K960806 (1996). 9 ancestors in all, the oldest K925813 (1994). 3 later devices descend from it, 3 citing it directly.

  1. Root · 6 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
  2. 5 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
  3. 4 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
  4. 3 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
  5. 2 generations backK113778 Excelsior XT-27 MicrocatheterStryker Neurovascular · 2012 · Recalled
  6. 1 generation backK123477 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013
  7. This deviceK132652 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013
  8. Descendant · cites it directly · 2 of its ownK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
  9. Descendant · cites it directly · 1 of its ownK162565 VIA 17 MicrocatheterSequent Medical, Inc. · 2017
  10. Descendant · cites it directly · 0 of its ownK192135 VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA…MicroVention, Inc. · 2019 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K150894VIA 21 MicrocatheterSequent Medical, Inc. · 2015 · cites it directly2descendants
  • K162565VIA 17 MicrocatheterSequent Medical, Inc. · 2017 · cites it directly1descendant
  • K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K960806Turbo TrackerTarget Therapeutics1996—
−5K994155Excelsior 1018 MicrocatheterBoston Scientific, Target2000—
−4K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target20012
−3K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp20047
−2K113778Excelsior XT-27 MicrocatheterStryker Neurovascular20123
−1K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.2013—
0 (this device)K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.2013—
+1K150894VIA 21 MicrocatheterSequent Medical, Inc.2015—
+1K162565VIA 17 MicrocatheterSequent Medical, Inc.2017—
+1K192135VIA 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
201510
201710
201910
FIG. 1 — Lineage of K132652, 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 DQY? 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (3)

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
…0 CLASSIFICATION PRODUCT CODES DQY: Percutaneous Catheter KRA: Continuous Flush Catheter PREDICATE Marksman Catheter (K09 1559) DEVICES Excelsior XT-27 M icrocatheter (KI 113778) PRIOR SUBMISSION There has been a prior submission for…
Chestnut Medical Technologies, Inc.2009—
*K113778Excelsior XT-27 Microcatheter
Summary page 3
…10(k) application was found to be substantially equivalent to all the predicate devices, including the MarksmanTM Catheter (K09 1559), the Excelsior XT-27 Microcatheter (K 113778) and the VIATM Microcatheter (K 123477) NONCLINICAL TESTrS DISCUSSION: The nonclinical tests included: * Physical characteri…
Stryker Neurovascular20123
*K123477Via Microcatheter, Via Plus Microcatheter
Summary page 1
…XT-27 M icrocatheter (KI 113778) PRIOR SUBMISSION There has been a prior submission for the subject device and approval was obtained under K 123477 for peripheral and coronary indications PURPOSE OF The purpose of this submission is to gain…
Sequent Medical, Inc.2013—

Also cleared against K091559: 4 other devices →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150894VIA 21 MicrocatheterSequent Medical, Inc.20152
K162565VIA 17 MicrocatheterSequent Medical, Inc.20171
K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc.20190

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 23, 2016Class IIZ-0114-2017Under Investigation by firmSequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.

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 9 ancestors have a recall of any class.
  • Of its descendants, K150894 (Sequent Medical, Inc., 2015) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K091559.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The VIATh Micracatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow, diverters) and infusion of diagnostic (such as contrast media), or therapeutic agents into the neuro, peripheral and coronary vasculature.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K132652: 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/K132652

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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