510(k) · Cleared
Recalled · Class I · 2016Vascular Solutions Twin-Pass Dual Access 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 Nov 23, 2005 after a 97-day review. The FDA summary names its predicate without a number. 2 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Nov 23, 2005
- Review
- 97 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1 (1 Class I)
- Predicates
- 0
12 later devices descend from it, 2 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- This deviceK052257 Vascular Solutions Twin-Pass Dual Access CatheterVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK072618 Twin-Pass Otw Catheter, Model 5201Vascular Solutions, Inc. · 2007
- Descendant · 2 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
- Descendant · 3 generations on · 3 of its ownK140910 Centercross CatheterRoxwood Medical, Inc. · 2014
- Descendant · 4 generations on · 2 of its ownK152456 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK143608 NovaCross MicrocatheterNitiloop, Ltd. · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K062877 Twin-Pass .023 Dual Access Catheter, Model 5230cites it directly · 2007
Most influential descendants
Showing 5 of 12 · See all- K072618Twin-Pass Otw Catheter, Model 5201Vascular Solutions, Inc. · 2007 · cites it directly10descendants
- K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 2 generations on8descendants
- K140910Centercross CatheterRoxwood Medical, Inc. · 2014 · 3 generations on3descendants
- K152456CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 4 generations on2descendants
- K143608NovaCross MicrocatheterNitiloop, Ltd. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052257 | Vascular Solutions Twin-Pass Dual Access Catheter | Vascular Solutions, Inc. | 2005 | — |
| +1 | K072618 | Twin-Pass Otw Catheter, Model 5201 | Vascular Solutions, Inc. | 2007 | — |
| +2 | K121763 | Multicross Support Catheter | Roxwood Medical, Inc. | 2012 | — |
| +3 | K140910 | Centercross Catheter | Roxwood Medical, Inc. | 2014 | — |
| +4 | K152456 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016 | — |
| +3 | K143608 | NovaCross Microcatheter | Nitiloop, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 1 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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.
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? (3)
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 |
|---|---|---|---|
| * | — | Lumend Percutaneous Catheter Named without a submission number | |
| * | — | Quick-Cross Catheter Named without a submission number | |
| * | — | Dual Lumen Catheter Named without a submission number |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0053-2017 | 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. |
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.
- K062877Twin-Pass .023 Dual Access Catheter, Model 5230Vascular Solutions, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K072618 (Vascular Solutions, Inc., 2007) has gone furthest, with 10 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 Dual Access Catheter is to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement of guidewires and other interventional devices, and for use during two guidewire procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052257: Vascular Solutions Twin-Pass Dual Access Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052257
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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