510(k) · Cleared
ClearedVascular Solutions Skyway Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DQY Catheter, Percutaneous
Cleared on Dec 13, 2005 as substantially equivalent to K011562 (Lumend, Inc., 2002) and 1 other predicate after a 116-day review. Its family tree reaches back 4 generations to 1994. 1 of the 89 devices in its family, counting itself, has a Class I recall. 80 later devices descend from it.
- Decided
- Dec 13, 2005
- Review
- 116 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K935425 (1994). 8 ancestors in all. 80 later devices descend from it, 2 citing it directly. 1 of the 89 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 3 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 2 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 1 generation backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- This deviceK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 44 of its ownK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
- Descendant · cites it directly · 35 of its ownK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
- Descendant · 2 generations on · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
- Descendant · 2 generations on · 20 of its ownK091345 Gopher Gold Catheter, Model 5620Vascular Solutions, Inc. · 2009
- Descendant · 3 generations on · 18 of its ownK102022 Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141547 Wingman Extendable Tip Support Catheter6 generations on · 2014
Most influential descendants
Showing 5 of 80 · See all- K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc. · 2007 · cites it directly44descendants
- K082337Minnie Support CatheterVascular Solutions, Inc. · 2009 · cites it directly35descendants
- K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · 2 generations on21descendants
- K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc. · 2009 · 2 generations on20descendants
- K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −3 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −2 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −1 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| 0 (this device) | K052258 | Vascular Solutions Skyway Support Catheter | Vascular Solutions, Inc. | 2005 | — |
| +1 | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| +1 | K082337 | Minnie Support Catheter | Vascular Solutions, Inc. | 2009 | — |
| +2 | K083313 | Wildcat 7F Guidewire Support Catheter | Avinger, Inc. | 2009 | — |
| +2 | K091345 | Gopher Gold Catheter, Model 5620 | Vascular Solutions, Inc. | 2009 | — |
| +3 | K102022 | Wildcat 6F Guidewire Support Catheter Model W400L and W400S | Avinger, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 1 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 8 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K011562 | Lumend Percutaneous Catheter | 2002 |
| * | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…Summary page 2…Technological Characteristics compared to Predicates: The Skyway Support Catheter is similar to the Lumend Percutaneous Catheter (KO1 1562) and the Quick-Cross Catheter )K033678) in shape, size, indications, materials and catheter type. Conclusions: The Skyway Support Catheter is substantially equivalent… | 2004 |
What descends from it? (80)
See all 802 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)
No FDA recall names this device.
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.
- K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K070372 (Vascular Solutions, Inc., 2007) has gone furthest, with 44 descendants of its own.
- 2 other devices also cite its predicate K011562.
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 Skyway Support Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature and to facilitate placement of guidewires and other interventional devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052258: Vascular Solutions Skyway 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/K052258
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