510(k) · Cleared
ClearedVIA 21 Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sequent Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 28, 2015 as substantially equivalent to K132652 (Sequent Medical, Inc., 2013) and 2 other predicates after a 148-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- Aug 28, 2015
- Review
- 148 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K960806 (1996). 23 ancestors in all, the oldest K925813 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 6 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 5 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 4 generations backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
- 3 generations backK113778 Excelsior XT-27 MicrocatheterStryker Neurovascular · 2012 · Recalled
- 2 generations backK123477 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013
- 1 generation backK132652 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · Recalled
- This deviceK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK162565 VIA 17 MicrocatheterSequent Medical, Inc. · 2017
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −6 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −5 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −4 | K042568 | Excelsior 1018 and SL-10 Microcatheters | Boston Scientific Corp | 2004 | 7 |
| −3 | K113778 | Excelsior XT-27 Microcatheter | Stryker Neurovascular | 2012 | 3 |
| −2 | K123477 | Via Microcatheter, Via Plus Microcatheter | Sequent Medical, Inc. | 2013 | — |
| −1 | K132652 | Via Microcatheter, Via Plus Microcatheter | Sequent Medical, Inc. | 2013 | 1 |
| 0 (this device) | K150894 | VIA 21 Microcatheter | Sequent Medical, Inc. | 2015 | — |
| +1 | K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | 2017 | — |
| +1 | 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 |
| 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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K132652 | Via Microcatheter, Via Plus MicrocatheterSummary page 4…atheter KRA: Continuous Flush Catheter PREDICATE VIA™ (VIA 27) and VIA™ PLUS (VIA 33) DEVICES Microcatheters (K132652) Headway 21 Microcatheter (K093160) Orion Microcatheter (K113289) PRIOR S… | 2013 |
| * | K093160 | Headway 21 Microcatheter, Model: MC212150SSummary page 4…ter PREDICATE VIA™ (VIA 27) and VIA™ PLUS (VIA 33) DEVICES Microcatheters (K132652) Headway 21 Microcatheter (K093160) Orion Microcatheter (K113289) PRIOR SUBMISSION This is an original submission. There has been no p… | 2009 |
| * | K113289 | Orion Micro CatheterSummary page 4…S (VIA 33) DEVICES Microcatheters (K132652) Headway 21 Microcatheter (K093160) Orion Microcatheter (K113289) PRIOR SUBMISSION This is an original submission. There has been no prior submission for the subject devi… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 23 ancestors have a recall of any class.
- Of its descendants, K162565 (Sequent Medical, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K132652.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The VIA™ 21 Microcatheter is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or non-liquid therapeutic agents into the neuro, peripheral, and coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150894: VIA 21 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150894
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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