510(k) · Cleared
ClearedConcierge Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 29, 2013 as substantially equivalent to K121051 (Merit Medical Systems, Inc., 2012) after a 27-day review. Its family tree reaches back 3 generations to 2004. 4 later devices descend from it.
- Decided
- Aug 29, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K033633 (2004). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK033633 Vascon Polaris Guiding CatheterVascon, LLC · 2004
- 2 generations backK043387 Vascon Polaris Guiding CatheterVascon, LLC · 2005
- 1 generation backK121051 Concierge Guiding CatheterMerit Medical Systems, Inc. · 2012
- This deviceK132409 Concierge Guiding CatheterMerit Medical Systems, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK253730 RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK191163 Lumax Guiding CatheterCook Incorporated · 2019
- Descendant · cites it directly · 0 of its ownK160561 Boosting CatheterQxmedical, LLC · 2016
Most influential descendants
Showing 4 of 4 · See all- K220780ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023 · cites it directly1descendant
- K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026 · 2 generations on0descendants
- K191163Lumax Guiding CatheterCook Incorporated · 2019 · cites it directly0descendants
- K160561Boosting CatheterQxmedical, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033633 | Vascon Polaris Guiding Catheter | Vascon, LLC | 2004 | — |
| −2 | K043387 | Vascon Polaris Guiding Catheter | Vascon, LLC | 2005 | — |
| −1 | K121051 | Concierge Guiding Catheter | Merit Medical Systems, Inc. | 2012 | — |
| 0 (this device) | K132409 | Concierge Guiding Catheter | Merit Medical Systems, Inc. | 2013 | — |
| +1 | K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023 | — |
| +2 | K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026 | — |
| +1 | K191163 | Lumax Guiding Catheter | Cook Incorporated | 2019 | — |
| +1 | K160561 | Boosting Catheter | Qxmedical, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K121051 | Concierge Guiding CatheterSummary page 1…Trade Name: Concierge® Guiding Catheter Predicate Classification Name: Percutaneous Catheter Device Premarket Notification: K1 21051 Manufacturer: Merit Medical Systems, Inc. Class 11 Classification 21 CFR § 870.12… | 2012 |
What descends from it? (4)
3 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 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220780 (2mg, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K121051.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ConciergeeD Guiding Catheter is intended for the intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132409 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132409: Concierge Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132409
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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