510(k) · Cleared
ClearedLeadliner CS Lead Delivery System
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 Feb 25, 2014 as substantially equivalent to K120158 (Thomas Medical Products, Inc., 2012) after a 103-day review. Its family tree reaches back 3 generations to 2000. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 25, 2014
- Review
- 103 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000659 (2000). 6 ancestors in all. No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK000659 Modification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc. · 2000 · Recalled
- 2 generations backK053171 Merit Impress Diagnostic CatheterMerit Medical Systems, Inc. · 2006
- 1 generation backK120158 Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc. · 2012 · Recalled
- This deviceK133501 Leadliner CS Lead Delivery SystemVascular Solutions, Inc. · 2014
Class I recalls in this family
- K001578 Angiodynamics Soft-VU Hydrophilic Coated…3 generations back · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000659 | Modification to Softouch Diagnostic Intravascular Cat | Merit Medical Systems, Inc. | 2000 | 1 |
| −2 | K053171 | Merit Impress Diagnostic Catheter | Merit Medical Systems, Inc. | 2006 | — |
| −1 | K120158 | Coronary Sinus Guide and Lateral Vein Introducer Kits | Thomas Medical Products, Inc. | 2012 | 2 |
| 0 (this device) | K133501 | Leadliner CS Lead Delivery System | Vascular Solutions, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 1 |
| 2001 | 1 | 0 |
| 2010 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K120158 | Coronary Sinus Guide and Lateral Vein Introducer KitsSummary page 1…LeadLiner CS lead delivery system Common / Usual Name Catheter, Percutaneous Classification Name Class 11- 870.1250 Predicate Device K(120158 - Lateral Vein Introducer Kit (Pressure Products) Device Description The LeadLiner CS lead delivery system (LeadLiner) is used… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K001578Angiodynamics Soft-VU Hydrophilic Coated Angiographic CatheterAngioDynamics, Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 4 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K120158.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 LeadLiner CS lead delivery system is intended for the introduction of pacing or dlefibrillator leads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133501: Leadliner CS Lead Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133501
Report an extraction error
Are you the manufacturer?
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