510(k) · Cleared
ClearedHeadway Duo Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 2, 2012 as substantially equivalent to K083343 (MicroVention, Inc., 2008) after a 128-day review. Its family tree reaches back 4 generations to 1996. 12 later devices descend from it.
- Decided
- Aug 2, 2012
- Review
- 128 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960806 (1996). 5 ancestors in all, the oldest K925813 (1994). 12 later devices descend from it, 1 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 backK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- This deviceK120917 Headway Duo MicrocatheterMicroVention, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK131482 Sofia Distal Access CatheterMicroVention, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK142014 Sofia Distal Access CatheterMicroVention, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK150366 SOFIA 6F CatheterMicroVention, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK201682 RIST Radial Access CatheterRist Neurovascular, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK182602 SOFIA EX Intracranial Support CatheterMicroVention, Inc. · 2019
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K131482Sofia Distal Access CatheterMicroVention, Inc. · 2013 · cites it directly11descendants
- K142014Sofia Distal Access CatheterMicroVention, Inc. · 2014 · 2 generations on7descendants
- K150366SOFIA 6F CatheterMicroVention, Inc. · 2015 · 2 generations on6descendants
- K201682RIST Radial Access CatheterRist Neurovascular, Inc. · 2020 · 3 generations on2descendants
- K182602SOFIA EX Intracranial Support CatheterMicroVention, Inc. · 2019 · 2 generations on2descendants
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 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| 0 (this device) | K120917 | Headway Duo Microcatheter | MicroVention, Inc. | 2012 | — |
| +1 | K131482 | Sofia Distal Access Catheter | MicroVention, Inc. | 2013 | — |
| +2 | K142014 | Sofia Distal Access Catheter | MicroVention, Inc. | 2014 | — |
| +2 | K150366 | SOFIA 6F Catheter | MicroVention, Inc. | 2015 | — |
| +3 | K201682 | RIST Radial Access Catheter | Rist Neurovascular, Inc. | 2020 | — |
| +2 | K182602 | SOFIA EX Intracranial Support Catheter | MicroVention, Inc. | 2019 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K083343 | Headway 17 MicrocatheterSummary page 1…Tustin, California U.S.A. Contact: Naomi Gong Date: 2012Mar23 Predicate Device: Headway 17 Microcatheter (K083343) Device Description: The Headway Duo Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewi… | 2008 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131482 | Sofia Distal Access Catheter | 2013 | 11 |
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 16 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K131482 (MicroVention, Inc., 2013) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K083343.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Headway Duo Microcatheter is intended for general intravascular use, including the peripheral and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.
The Headway Duo Microcatheter is intended for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use in the neurovasculature and are compatible with the inner diameter of the Headway Duo Microcatheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120917 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120917: Headway Duo Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120917
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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