510(k) · Cleared
Recalled · Class II · 2017Excelsior XT-27 Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Neurovascular · DQY Catheter, Percutaneous
Cleared on Apr 20, 2012 as substantially equivalent to K000177 (Boston Scientific Corp, 2000) and 1 other predicate after a 120-day review. Its family tree reaches back 4 generations to 1996. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 20, 2012
- Review
- 120 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960806 (1996). 6 ancestors in all, the oldest K925813 (1994). 8 later devices descend from it, 4 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 deviceK113778 Excelsior XT-27 MicrocatheterStryker Neurovascular · 2012
- Descendant · cites it directly · 4 of its ownK123477 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK132652 Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK150894 VIA 21 MicrocatheterSequent Medical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK162565 VIA 17 MicrocatheterSequent Medical, Inc. · 2017
- 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- K123477Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · cites it directly4descendants
- K132652Via Microcatheter, Via Plus MicrocatheterSequent Medical, Inc. · 2013 · cites it directly3descendants
- K150894VIA 21 MicrocatheterSequent Medical, Inc. · 2015 · 2 generations on2descendants
- K162565VIA 17 MicrocatheterSequent Medical, Inc. · 2017 · 2 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 |
|---|---|---|---|---|---|
| −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) | K113778 | Excelsior XT-27 Microcatheter | Stryker Neurovascular | 2012 | — |
| +1 | K123477 | Via Microcatheter, Via Plus Microcatheter | Sequent Medical, Inc. | 2013 | — |
| +1 | K132652 | Via Microcatheter, Via Plus Microcatheter | Sequent Medical, Inc. | 2013 | 1 |
| +2 | K150894 | VIA 21 Microcatheter | Sequent Medical, Inc. | 2015 | — |
| +2 | K162565 | VIA 17 Microcatheter | Sequent Medical, Inc. | 2017 | — |
| +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 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K000177 | Renegade HI-Flo MicrocatheterSummary page 1…47900 Bayside Parkway Fremont, CA 94538-65 15 Contact: Yoko Y Enrile Predicate Device: K000 177, RenegadeTM Hi-FloTM Microcatheter K042568, Excelsior®P SL-10 Pre-Shaped Microcatheter Indications… | 2000 |
| * | K042568 | Excelsior 1018 and SL-10 MicrocathetersSummary page 1…Fremont, CA 94538-65 15 Contact: Yoko Y Enrile Predicate Device: K000 177, RenegadeTM Hi-FloTM Microcatheter K042568, Excelsior®P SL-10 Pre-Shaped Microcatheter Indications for Use: The Excelsior XT-27 Microcatheter is intended to assist in the… | 2004 |
What descends from it? (8)
4 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 |
|---|---|---|---|---|
| Nov 3, 2017 | Class II | Z-0275-2018 | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
| Nov 3, 2017 | Class II | Z-0276-2018 | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
| Nov 3, 2017 | Class II | Z-0277-2018 | Labeling Change Control | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K123477 (Sequent Medical, Inc., 2013) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K000177.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Excelsior XT-27 Microcatheter is intended to assist in the delivery of diagnostic agents (such as contrast media), therapeutic agents, and non-liquid interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113778: Excelsior XT-27 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113778
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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