510(k) · Cleared
ClearedVascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)
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 Sep 23, 2004 as substantially equivalent to K914141 (Cordis Corp., 1991) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1981. 2 of the 11 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Sep 23, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K810412 (1981). 3 ancestors in all. 7 later devices descend from it, 1 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK810412 Usci Cardiovascular CatheterC.R. Bard, Inc. · 1981
- This deviceK041909 Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK061565 Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK062627 Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK170544 Langston dual lumen catheterVascular Solutions, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK073585 Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902…Vascular Solutions, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK222023 RayFlowHexacath · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · cites it directly6descendants
- K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007 · 2 generations on2descendants
- K170544Langston dual lumen catheterVascular Solutions, Inc. · 2017 · 2 generations on1descendant
- K073585Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905Vascular Solutions, Inc. · 2008 · 3 generations on1descendant
- K222023RayFlowHexacath · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810412 | Usci Cardiovascular Catheter | C.R. Bard, Inc. | 1981 | — |
| 0 (this device) | 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 |
| +2 | K062627 | Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 | Vascular Solutions, Inc. | 2007 | — |
| +2 | K170544 | Langston dual lumen catheter | Vascular Solutions, Inc. | 2017 | — |
| +3 | K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and… | Vascular Solutions, Inc. | 2008 | — |
| +3 | K222023 | RayFlow | Hexacath | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
| 2007 | 2 | 1 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K914141 | Cordis Dual Lumen Pressure Monitoring CatheterSummary page 2…have been conducted. Predicate Devices: The Dual Lumen Pigtail catheter is similar in intended use and function to the Cordis Dual Lumen Pressure Monitoring Catheter (1(914141), the USCI Cardiovascular Catheter (K943739), and the Merit Medical Softouch Diagnostic Intravascular Catheter (K810412). Conclu… | 1991 |
| * | K943739 | Softouch Diagnostic Intravascular CatheterSummary page 1…ement catheter and for delivery of contrast media during angiographic studies. The DLP catheter consists of the Merit Medical Softouch Diagnostic Intravascular Catheter (K943739) as the inner lumen and an extruded outer lumen designed by Vascular Solutions. The inner lumen and hub assembly are purchased fr… | 1994 |
| * | K810412 | Usci Cardiovascular CatheterSummary page 2…Cordis Dual Lumen Pressure Monitoring Catheter (1(914141), the USCI Cardiovascular Catheter (K943739), and the Merit Medical Softouch Diagnostic Intravascular Catheter (K810412). Conclusions: The Dual Lumen Pigtail Catheter is substantially equivalent to the Cordis Dual Lumen Pressure Monitoring Catheter… | 1981 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061565 | Langston Dual Lumen Catheter Class I | 2006 | 6 |
Has anything in its family been recalled? (2 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.
- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K062877Twin-Pass .023 Dual Access Catheter, Model 5230Vascular Solutions, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K061565 (Vascular Solutions, Inc., 2006) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Vascular Solutions Langston TM Dual Lumen Pigtail Catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041909 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041909: Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041909
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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