510(k) · Cleared
Recalled · Class I · 2016Twin-Pass .023 Dual Access Catheter, Model 5230
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 18, 2007 as substantially equivalent to K052257 (Vascular Solutions, Inc., 2005) and 1 other predicate after a 114-day review. Its family tree reaches back 3 generations to 1981. 4 of the 9 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Jan 18, 2007
- Review
- 114 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K810412 (1981). 8 ancestors in all. No later device cites it as a predicate yet. 4 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK810412 Usci Cardiovascular CatheterC.R. Bard, Inc. · 1981
- 2 generations backK041909 Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc. · 2004
- 1 generation backK061565 Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Recalled (Class I)
- This deviceK062877 Twin-Pass .023 Dual Access Catheter, Model 5230Vascular Solutions, Inc. · 2007
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810412 | Usci Cardiovascular Catheter | C.R. Bard, Inc. | 1981 | — |
| −2 | K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) | Vascular Solutions, Inc. | 2004 | — |
| −1 | K061565 | Langston Dual Lumen Catheter | Vascular Solutions, Inc. | 2006 | Class I |
| 0 (this device) | K062877 | Twin-Pass .023 Dual Access Catheter, Model 5230 | Vascular Solutions, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 3 | 2 |
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.
4 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K052257 | Vascular Solutions Twin-Pass Dual Access CatheterSummary page 2…assification Name: Diagnostic intravascular catheter (21 CFR 870.1200, Product Code DQO) Predicate Devices Twin-Pass Dual Access Catheter (K052257), manufactured by Vascular Solutions, Inc. Langston Dual Lumen Catheter (K061565), manufactured by Vascular Solutions, Inc. D… | 2005 |
| * | K061565 | Langston Dual Lumen CatheterSummary page 2…CFR 870.1200, Product Code DQO) Predicate Devices Twin-Pass Dual Access Catheter (K052257), manufactured by Vascular Solutions, Inc. Langston Dual Lumen Catheter (K061565), manufactured by Vascular Solutions, Inc. Device Description The Twin-Pass .023" catheter has a polymeric dual-lumen design.… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2016 | Class I | Z-0055-2017 | 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.
- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K052257Vascular Solutions Twin-Pass Dual Access CatheterVascular Solutions, Inc. · 2005 · Direct predicate · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K051395Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 8 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K052257.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Twin-Pass .023" catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral 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 Twin-Pass .023" catheter is additionally intended to be used to measure intra-arterial pressure within the peripheral and coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062877: Twin-Pass .023 Dual Access Catheter, Model 5230.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062877
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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