510(k) · Cleared
ClearedVascon Polaris Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascon, LLC · DQY Catheter, Percutaneous
Cleared on Feb 16, 2005 as substantially equivalent to K033633 (Vascon, LLC, 2004) after a 69-day review. Its family tree reaches back 1 generation to 2004. 8 later devices descend from it.
- Decided
- Feb 16, 2005
- Review
- 69 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033633 (2004). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK033633 Vascon Polaris Guiding CatheterVascon, LLC · 2004
- This deviceK043387 Vascon Polaris Guiding CatheterVascon, LLC · 2005
- Descendant · cites it directly · 6 of its ownK121051 Concierge Guiding CatheterMerit Medical Systems, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK132409 Concierge Guiding CatheterMerit Medical Systems, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK220780 ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK253730 RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK191163 Lumax Guiding CatheterCook Incorporated · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K121051Concierge Guiding CatheterMerit Medical Systems, Inc. · 2012 · cites it directly6descendants
- K132409Concierge Guiding CatheterMerit Medical Systems, Inc. · 2013 · 2 generations on4descendants
- K220780ROVO Mechanical Thrombectomy Device2mg, Inc. · 2023 · 2 generations on1descendant
- K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc. · 2026 · 3 generations on0descendants
- K191163Lumax Guiding CatheterCook Incorporated · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033633 | Vascon Polaris Guiding Catheter | Vascon, LLC | 2004 | — |
| 0 (this device) | K043387 | Vascon Polaris Guiding Catheter | Vascon, LLC | 2005 | — |
| +1 | K121051 | Concierge Guiding Catheter | Merit Medical Systems, Inc. | 2012 | — |
| +2 | K132409 | Concierge Guiding Catheter | Merit Medical Systems, Inc. | 2013 | — |
| +2 | K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | 2023 | — |
| +3 | K253730 | RoVo Mechanical Thrombectomy System | Verge Medical, Inc. | 2026 | — |
| +3 | K191163 | Lumax Guiding Catheter | Cook Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K033633 | Vascon Polaris Guiding CatheterSummary page 1…assification Name: Percutaneous Catheter Trade Name: VasCon PolarisTM Guiding Catheter Predicate Device VasCon PolarisTM Guiding Catheters, 510(k) K033633 Intended Use The guiding catheter is intended for use for intravascular introduction of interventional… | 2004 |
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?
- Its one ancestor has no recall.
- Of its descendants, K121051 (Merit Medical Systems, Inc., 2012) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 guiding catheter is intended for use for 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/K043387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043387: Vascon Polaris Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043387
Report an extraction error
Are you the manufacturer?
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