510(k) · Cleared
ClearedGORE Tri-Lumen Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore and Associates, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 5, 2018 as substantially equivalent to K072618 (Vascular Solutions, Inc., 2007) after a 179-day review. Its family tree reaches back 2 generations to 2005. 2 of the 4 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 5, 2018
- Review
- 179 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052257 (2005). 3 ancestors in all. No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK052257 Vascular Solutions Twin-Pass Dual Access CatheterVascular Solutions, Inc. · 2005 · Recalled (Class I)
- 1 generation backK072618 Twin-Pass Otw Catheter, Model 5201Vascular Solutions, Inc. · 2007
- This deviceK180919 GORE Tri-Lumen CatheterW. L. Gore and Associates, Inc. · 2018
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052257 | Vascular Solutions Twin-Pass Dual Access Catheter | Vascular Solutions, Inc. | 2005 | Class I |
| −1 | K072618 | Twin-Pass Otw Catheter, Model 5201 | Vascular Solutions, Inc. | 2007 | — |
| 0 (this device) | K180919 | GORE Tri-Lumen Catheter | W. L. Gore and Associates, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 1 |
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? (1)
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 |
|---|---|---|---|
| * | K072618 | Twin-Pass Otw Catheter, Model 5201Summary page 4…250 Classification Panel: Cardiovascular Devices Establishment Registration Number: 2017233 Predicate Device: K072618, Twin-Pass Dual Access Catheter, Vascular Solutions, Inc.… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K052257Vascular Solutions Twin-Pass Dual Access CatheterVascular Solutions, Inc. · 2005 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- 2 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K072618.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180919 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180919: GORE Tri-Lumen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180919
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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