510(k) · Cleared
Recalled · Class I · 2016Vascular Solutions Twin-Pass Dual Access Catheter and 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 Apr 12, 2006 after a 62-day review. The FDA summary names its predicate without a number. 2 of the 102 devices in its family, counting itself, have a Class I recall. 101 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Apr 12, 2006
- Review
- 62 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 2 (1 Class I)
- Predicates
- 0
101 later devices descend from it, 7 citing it directly. 2 of the 102 devices in this family, counting this one, have a Class I recall.
- This deviceK060327 Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support…Vascular Solutions, Inc. · 2006
- 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 101 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 101 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K060327 | Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter | Vascular Solutions, Inc. | 2006 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 7 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 9 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 1 |
| 2015 | 4 | 0 |
| 2016 | 11 | 0 |
| 2017 | 11 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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.
2 devices in this family have 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? (4)
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 |
|---|---|---|---|
| * | — | Pivot Steerable Microcatheter Named without a submission number | |
| * | — | Twin-Pass Dual Access Catheter Named without a submission number | |
| * | — | Skyway Support Catheter Named without a submission number | |
| * | — | Langston Dual Lumen Pressure Monitoring Catheter Named without a submission number |
What descends from it? (101)
See all 1017 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610 | 2007 | 44 |
| K082337 | Minnie Support Catheter | 2009 | 35 |
| K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010… | 2009 | 10 |
| K072618 | Twin-Pass Otw Catheter, Model 5201 | 2007 | 10 |
| K193119 | Twin-Pass Dual Access Catheter | 2020 | 1 |
| K182844 | Asahi Sasuke | 2019 | 0 |
| K101117 | Lev-or Dilation Catheter Otw | 2010 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2016 | Class I | Z-0054-2017 | Process control | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. |
| Jul 2, 2009 | Not classified | Z-1712-2009 | Process control | Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is… |
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?
- Of its descendants, K070372 (Vascular Solutions, Inc., 2007) has gone furthest, with 44 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 Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents. The Skyway support catheters are intended to be used in conjunction with steerable…
Read the full statement (105 words)
The Twin-Pass catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
The Skyway support catheters are intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The Skyway OTW also may be used to subselectively infuse/deliver therapeutic agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060327 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060327: Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060327
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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