510(k) Report

510(k) · Cleared

Cleared

VIA 17 Microcatheter

K162565510(k) TraditionalCleared Feb 18, 2017157-day reviewClass II21 CFR 870.1250

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 Feb 18, 2017 as substantially equivalent to K150894 (Sequent Medical, Inc., 2015) and 2 other predicates after a 157-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.

Decided
Feb 18, 2017
Review
157 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
3

Its longest line of descent runs back 8 generations to K960806 (1996). 25 ancestors in all, the oldest K925813 (1994). 1 later device descends from it, 1 citing it directly.

  1. Root · 8 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
  2. 7 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
  3. 6 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
  4. 5 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
  5. 4 generations backK113778 Excelsior XT-27 MicrocatheterStryker Neurovascular · 2012 · Recalled
  6. 3 generations backK123477 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013
  7. 2 generations backK132652 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · Recalled
  8. 1 generation backK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
  9. This deviceK162565 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 1 of 1 · See all
  • 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
−8K960806Turbo TrackerTarget Therapeutics1996—
−7K994155Excelsior 1018 MicrocatheterBoston Scientific, Target2000—
−6K013789Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target20012
−5K042568Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp20047
−4K113778Excelsior XT-27 MicrocatheterStryker Neurovascular20123
−3K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.2013—
−2K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc.20131
−1K150894VIA 21 MicrocatheterSequent Medical, Inc.2015—
0 (this device)K162565VIA 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
199520
199720
199810
199910
200020
200110
200220
200810
200920
201010
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K162565, 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
Get a 510(k) Report

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
*K150894VIA 21 Microcatheter
Summary page 4
…ICATION PRODUCT CODES DQY: Percutaneous Catheter KRA: Continuous Flush Catheter PREDICATE VIA™ 21 Microcatheter (K150894) DEVICES VIA™ and VIA™ PLUS Microcatheters (K132652) Headway 17 Advanced Microcathe…
Sequent Medical, Inc.2015—
*K132652Via Microcatheter, Via Plus Microcatheter
Summary page 4
…KRA: Continuous Flush Catheter PREDICATE VIA™ 21 Microcatheter (K150894) DEVICES VIA™ and VIA™ PLUS Microcatheters (K132652) Headway 17 Advanced Microcatheter (K101542) SUBSTANTIALLY EQUIVALENT TO: The VIA™ 17 Microcatheter…
Sequent Medical, Inc.20131
*K101542Headway 17 Advanced Microcatheter
Summary page 4
…VIA™ 21 Microcatheter (K150894) DEVICES VIA™ and VIA™ PLUS Microcatheters (K132652) Headway 17 Advanced Microcatheter (K101542) SUBSTANTIALLY EQUIVALENT TO: The VIA™ 17 Microcatheter is substantially equivalent to the previously cleared VIA 21 Microcathe…
MicroVention, Inc.20101

Also cleared against K150894: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
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)

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 21 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
  • 8 of the 25 ancestors have a recall of any class.
  • Of its descendants, K192135 (MicroVention, Inc., 2019) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K150894.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 VIA™ 17 Microcatheter is intended for the introduction of non-liquid interventional devices (such as coils/stents) and infusion of diagnostic agents (such as contrast media) 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. “K162565: VIA 17 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162565

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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