510(k) · Cleared
Recalled · Class III · 2021VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · DQY Catheter, Percutaneous
Cleared on Dec 24, 2019 as substantially equivalent to K150894 (Sequent Medical, Inc., 2015) and 2 other predicates after a 139-day review. Its family tree reaches back 9 generations to 1996. It has been recalled 3 times.
- Decided
- Dec 24, 2019
- Review
- 139 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 9 generations to K960806 (1996). 26 ancestors in all, the oldest K925813 (1994). No later device cites it as a predicate yet.
- Root · 9 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 5 generations between
- 3 generations backK132652 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · Recalled
- 2 generations backK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
- 1 generation backK162565 VIA 17 MicrocatheterSequent Medical, Inc. · 2017
- This deviceK192135 VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA…MicroVention, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 8 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 7 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 6 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
- 5 generations backK113778 Excelsior XT-27 MicrocatheterStryker Neurovascular · 2012 · Recalled
- 4 generations backK123477 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013
- 3 generations backK132652 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · Recalled
- 2 generations backK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
- 1 generation backK162565 VIA 17 MicrocatheterSequent Medical, Inc. · 2017
- This deviceK192135 VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA…MicroVention, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −8 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −7 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −6 | K042568 | Excelsior 1018 and SL-10 Microcatheters | Boston Scientific Corp | 2004 | 7 |
| −5 | K113778 | Excelsior XT-27 Microcatheter | Stryker Neurovascular | 2012 | 3 |
| −4 | K123477 | Via Microcatheter, Via Plus Microcatheter | Sequent Medical, Inc. | 2013 | — |
| −3 | K132652 | Via Microcatheter, Via Plus Microcatheter | Sequent Medical, Inc. | 2013 | 1 |
| −2 | K150894 | VIA 21 Microcatheter | Sequent Medical, Inc. | 2015 | — |
| −1 | K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | 2017 | — |
| 0 (this device) | K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter… | MicroVention, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 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 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150894 | VIA 21 MicrocatheterSummary page 4…210) Regulatory Class Class II Classification Product Code DQY Subsequent Product Code KRA III. PREDICATE DEVICE VIA® Microcatheter (K150894, K132652, K162565) manufactured by Sequent Medical Inc. (SMI). IV. REFERENCE DEVICE Headway Microcatheter (K101542, K110813… | 2015 |
| * | K132652 | Via Microcatheter, Via Plus MicrocatheterSummary page 4…latory Class Class II Classification Product Code DQY Subsequent Product Code KRA III. PREDICATE DEVICE VIA® Microcatheter (K150894, K132652, K162565) manufactured by Sequent Medical Inc. (SMI). IV. REFERENCE DEVICE Headway Microcatheter (K101542, K110813) manufac… | 2013 |
| * | K162565 | VIA 17 MicrocatheterSummary page 4…ass Class II Classification Product Code DQY Subsequent Product Code KRA III. PREDICATE DEVICE VIA® Microcatheter (K150894, K132652, K162565) manufactured by Sequent Medical Inc. (SMI). IV. REFERENCE DEVICE Headway Microcatheter (K101542, K110813) manufactured by… | 2017 |
| † | K101542 | Headway 17 Advanced Microcatheter | 2010 |
| † | K110813 | Headway 27 Microcatheter | 2011 |
| † | K110741 | Scepter C Occlusion Balloon Catheter | 2011 |
| † | K121785 | Scepter C Occlusion Balloon Catheter | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2021 | Class III | Z-1828-2021 | Labeling Change Control | Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. |
| Apr 21, 2021 | Class III | Z-1830-2021 | Labeling Change Control | Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. |
| Apr 21, 2021 | Class III | Z-1829-2021 | Labeling Change Control | Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K150894.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
VIA 21, 27, 33 - The VIA® Microcatheter is intended for the introduction of interventional devices (such as the WEB device/stents/flow diverters) and infusion of diagnostic agents (such as contrast media) into the neuro, peripheral, and coronary vasculature.
VIA 17, 17 Preshaped 45°, 17 Preshaped 90° - The VIA® Microcatheter is intended for the introduction of 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.
https://510kreport.com/device/K192135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192135: VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192135
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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