510(k) · Cleared
ClearedHeadway 27 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 5, 2011 as substantially equivalent to K093160 (MicroVention, Inc., 2009) after a 134-day review. Its family tree reaches back 5 generations to 1996. 8 later devices descend from it.
- Decided
- Aug 5, 2011
- Review
- 134 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K960806 (1996). 6 ancestors in all, the oldest K925813 (1994). 8 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 4 generations backK994155 Excelsior 1018 MicrocatheterBoston Scientific, Target · 2000
- 3 generations backK013789 Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189Boston Scientific, Target · 2001 · Recalled
- 2 generations backK083343 Headway 17 MicrocatheterMicroVention, Inc. · 2008
- 1 generation backK093160 Headway 21 Microcatheter, Model: MC212150SMicroVention, Inc. · 2009
- This deviceK110813 Headway 27 MicrocatheterMicroVention, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK142449 Headway 27 MicrocatheterMicroVention, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK192625 PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company · 2019
- Descendant · 3 generations on · 2 of its ownK231600 SENDERO MicrocatheterOkami Medical, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK240384 SENDERO MicrocatheterOkami Medical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK130858 Reverse Medical MicrocatheterReverse Medical Corporation · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142449Headway 27 MicrocatheterMicroVention, Inc. · 2015 · cites it directly5descendants
- K192625PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company · 2019 · 2 generations on3descendants
- K231600SENDERO MicrocatheterOkami Medical, Inc. · 2023 · 3 generations on2descendants
- K240384SENDERO MicrocatheterOkami Medical, Inc. · 2024 · 4 generations on1descendant
- K130858Reverse Medical MicrocatheterReverse Medical Corporation · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −4 | K994155 | Excelsior 1018 Microcatheter | Boston Scientific, Target | 2000 | — |
| −3 | K013789 | Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001 | 2 |
| −2 | K083343 | Headway 17 Microcatheter | MicroVention, Inc. | 2008 | — |
| −1 | K093160 | Headway 21 Microcatheter, Model: MC212150S | MicroVention, Inc. | 2009 | — |
| 0 (this device) | K110813 | Headway 27 Microcatheter | MicroVention, Inc. | 2011 | — |
| +1 | K142449 | Headway 27 Microcatheter | MicroVention, Inc. | 2015 | — |
| +2 | K192625 | PG Pro Microcatheter | MicroVention, Inc. A TERUMO Group Company | 2019 | — |
| +3 | K231600 | SENDERO Microcatheter | Okami Medical, Inc. | 2023 | — |
| +4 | K240384 | SENDERO Microcatheter | Okami Medical, Inc. | 2024 | — |
| +1 | K130858 | Reverse Medical Microcatheter | Reverse Medical Corporation | 2013 | — |
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 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K093160 | Headway 21 Microcatheter, Model: MC212150SSummary page 1…Tustin, California U.S.A. Contact: Naomi Gong Date: 2011 Mar23 Predicate Device: Headway 21 Microcatheter (K093 160) Device Description: The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire… | 2009 |
What descends from it? (8)
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 15 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K142449 (MicroVention, Inc., 2015) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K093160.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature 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/K110813 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110813: Headway 27 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110813
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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