510(k) · Cleared
Recalled · Class II · 2024Headway 17 Advanced Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 6, 2010 as substantially equivalent to K083343 (MicroVention, Inc., 2008) and 1 other predicate after a 64-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 6, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960806 (1996). 6 ancestors in all, the oldest K925813 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 3 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 2 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 1 generation backK042568 Excelsior 1018 and SL-10 MicrocathetersBoston Scientific Corp · 2004 · Recalled
- This deviceK101542 Headway 17 Advanced MicrocatheterMicroVention, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK162565 VIA 17 MicrocatheterSequent Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK254071 p17 XR MicrocatheterWallaby Medical · 2026
- 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 3 of 3 · See all- K162565VIA 17 MicrocatheterSequent Medical, Inc. · 2017 · cites it directly1descendant
- K254071p17 XR MicrocatheterWallaby Medical · 2026 · cites it directly0descendants
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −3 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −2 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −1 | K042568 | Excelsior 1018 and SL-10 Microcatheters | Boston Scientific Corp | 2004 | 7 |
| 0 (this device) | K101542 | Headway 17 Advanced Microcatheter | MicroVention, Inc. | 2010 | — |
| +1 | K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | 2017 | — |
| +1 | K254071 | p17 XR Microcatheter | Wallaby Medical | 2026 | — |
| +2 | 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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083343 | Headway 17 MicrocatheterSummary page 1…e . Tustin, California U.S.A. ‘AU 0 62010 714-247-8000 Contact: Naomi Gong Date Prepared: February 26, 2010 Predicate Devices R '3& ';3}‘ r"“ “t P .23?‘,'.' D ,)f-;:".;- K083343 MicroVention - Headway 17 December 4, 2008 ' Microcatheter K042568 Boston Scientific, Excelsior SL-10 October 15, 2004 ' Preshape… | 2008 |
| * | K042568 | Excelsior 1018 and SL-10 MicrocathetersSummary page 1…mi Gong Date Prepared: February 26, 2010 Predicate Devices R '3& ';3}‘ r"“ “t P .23?‘,'.' D ,)f-;:".;- K083343 MicroVention - Headway 17 December 4, 2008 ' Microcatheter K042568 Boston Scientific, Excelsior SL-10 October 15, 2004 ' Preshaped Microcatheter Device Description: The Headway 17 Advanced Micro… | 2004 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2024 | Class II | Z-0990-2025 | Packaging process control | Sterility assurance; microcatheter inner packaging may contain incomplete seal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K162565 (Sequent Medical, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K083343.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Headway 17 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
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/K101542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101542: Headway 17 Advanced Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101542
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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