510(k) · Cleared
Recalled · 2009Trailblazer Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 7, 2009 as substantially equivalent to K072750 (Spectranetics Corp., 2007) and 1 other predicate after a 9-day review. Its family tree reaches back 6 generations to 1994. 1 of the 15 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 7, 2009
- Review
- 9 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K935425 (1994). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 5 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 4 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 3 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- 2 generations backK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
- 1 generation backK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
- This deviceK092299 Trailblazer Support CatheterEv3, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK170914 TXM Support CatheterTexasmedical Technologies, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK162384 TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) · 2016
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…2 generations back · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −5 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −4 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −3 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| −2 | K052258 | Vascular Solutions Skyway Support Catheter | Vascular Solutions, Inc. | 2005 | — |
| −1 | K082337 | Minnie Support Catheter | Vascular Solutions, Inc. | 2009 | — |
| 0 (this device) | K092299 | Trailblazer Support Catheter | Ev3, Inc. | 2009 | — |
| +1 | K170914 | TXM Support Catheter | Texasmedical Technologies, Inc. | 2017 | — |
| +1 | K162384 | TrailBlazer Angled Support Catheter | Medtronic Vascular, Inc.(Formerly Ev3 Inc.) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K072750 | Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066Summary page 1…0), Product Code DQY Classification Panel Cardiovascular Predicate Devices Spectranetics Quick-CrossT M Support 2 Catheters (K072750) Vascular Solutions Minnie Support Catheter (K082337)… | 2007 |
| * | K082337 | Minnie Support CatheterSummary page 1…ate Devices Spectranetics Quick-CrossT M Support 2 Catheters (K072750) Vascular Solutions Minnie Support Catheter (K082337) M Intended use TrailB… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2009 | Not classified | Z-0497-2010 | Component design/selection | Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 12 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K170914 (Texasmedical Technologies, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K072750.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
TrailBlazerTM Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TrailBlazerTM Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092299: Trailblazer Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092299
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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