510(k) · Cleared
ClearedSurefire Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surefire Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Feb 26, 2014 as substantially equivalent to K030779 (Medtronic Vascular, 2003) after a 50-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Feb 26, 2014
- Review
- 50 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981198 (1998). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
- 2 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
- 1 generation backK030779 5F Medtronic Launcher Guide CatheterMedtronic Vascular · 2003 · Recalled
- This deviceK140034 Surefire Guiding CatheterSurefire Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK233858 TriSalus TriGuideTM Guiding CatheterTrisalus Life Sciences · 2023
- Descendant · cites it directly · 0 of its ownK162359 Surefire Guiding CatheterSurefire Medical, Inc. · 2016
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 |
|---|---|---|---|---|---|
| −3 | K981198 | Medtronic Zuma Guiding Catheter | Medtronics Interventional Vascular | 1998 | 25 |
| −2 | K021256 | Z3 Guide Catheter | Medtronic Vascular | 2002 | 52 |
| −1 | K030779 | 5F Medtronic Launcher Guide Catheter | Medtronic Vascular | 2003 | 7 |
| 0 (this device) | K140034 | Surefire Guiding Catheter | Surefire Medical, Inc. | 2014 | — |
| +1 | K233858 | TriSalus TriGuideTM Guiding Catheter | Trisalus Life Sciences | 2023 | — |
| +1 | K162359 | Surefire Guiding Catheter | Surefire Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K030779 | 5F Medtronic Launcher Guide CatheterSummary page 1…vascular Devices Classification Regulation: 21 CFR 870.1250 Product Code: OQY Predicate Device * Medtronic Launcher Guiding Catheter K030779 Device Description The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into… | 2003 |
| † | K110459 | Surefire Infusion Catheter System | 2011 |
| † | K121677 | Surefire HI-Flow Microcatheter | 2012 |
| † | K122506 | Surefire High Flow Angiographic Catheter, Access | 2012 |
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? (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 3.8 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K233858 (Trisalus Life Sciences, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K030779.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140034: Surefire Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140034
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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