510(k) · Cleared
ClearedHeadway 17 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 Dec 4, 2008 as substantially equivalent to K013789 (Boston Scientific, Target, 2001) after a 21-day review. Its family tree reaches back 3 generations to 1996. 39 later devices descend from it.
- Decided
- Dec 4, 2008
- Review
- 21 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960806 (1996). 4 ancestors in all, the oldest K925813 (1994). 39 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 2 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 1 generation backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- This deviceK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- Descendant · cites it directly · 19 of its ownK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
- Descendant · cites it directly · 12 of its ownK120917 Headway Duo MicrocatheterMicroVention, Inc. · 2012
- Descendant · 2 generations on · 11 of its ownK131482 Sofia Distal Access CatheterMicroVention, Inc. · 2013
- Descendant · 2 generations on · 8 of its ownK110813 Headway 27 MicrocatheterMicroVention, Inc. · 2011
- Descendant · 3 generations on · 7 of its ownK142014 Sofia Distal Access CatheterMicroVention, Inc. · 2014
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K093160Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009 · cites it directly19descendants
- K120917Headway Duo MicrocatheterMicroVention, Inc. · 2012 · cites it directly12descendants
- K131482Sofia Distal Access CatheterMicroVention, Inc. · 2013 · 2 generations on11descendants
- K110813Headway 27 MicrocatheterMicroVention, Inc. · 2011 · 2 generations on8descendants
- K142014Sofia Distal Access CatheterMicroVention, Inc. · 2014 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −2 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −1 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| 0 (this device) | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| +1 | K093160 | Headway 21 Microcatheter, Model: MC212150S | MicroVention, Inc. | 2009 | — |
| +1 | K120917 | Headway Duo Microcatheter | MicroVention, Inc. | 2012 | — |
| +2 | K131482 | Sofia Distal Access Catheter | MicroVention, Inc. | 2013 | — |
| +2 | K110813 | Headway 27 Microcatheter | MicroVention, Inc. | 2011 | — |
| +3 | K142014 | Sofia Distal Access Catheter | MicroVention, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Summary page 1…, California U.S.A. Contact: Florin Truuvert Predicate Device: Number Description Predicate For Clearance Date K013789 Boston Scientific Headway 17 Dec 06, 2001 Excelsior SL- 10 Mi… | 2001 |
What descends from it? (39)
See all 396 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 12 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K093160 (MicroVention, Inc., 2009) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K013789.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 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 as stated in the FDA summary.
https://510kreport.com/device/K083343 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083343: Headway 17 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083343
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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