510(k) · Cleared
Recalled · 2012Guideliner V2 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 Dec 1, 2011 as substantially equivalent to K091750 (Vascular Solutions, Inc., 2009) after a 133-day review. Its family tree reaches back 7 generations to 1994. 1 of the 26 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it. It has been recalled once.
- Decided
- Dec 1, 2011
- Review
- 133 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K935425 (1994). 13 ancestors in all. 12 later devices descend from it, 3 citing it directly. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 6 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 5 generations backK022138 Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp. · 2002
- 4 generations backK033678 Spectranetics Quick Cross Catheters, Models 518-032, 518-033…Spectranetics Corp. · 2004
- 3 generations backK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
- 2 generations backK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
- 1 generation backK091750 Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc. · 2009
- This deviceK112082 Guideliner V2 CatheterVascular Solutions, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK172090 GuideLiner V3 CatheterVascular Solutions, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK183353 Telescope Guide Extension CatheterMedtronic, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK242276 CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)Vantis Vascular, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK220691 LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter…Seigla Medical, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK210110 GuidionImds Operations B.V. · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…3 generations back · 2006
Most influential descendants
Showing 5 of 12 · See all- K172090GuideLiner V3 CatheterVascular Solutions, Inc. · 2017 · cites it directly8descendants
- K183353Telescope Guide Extension CatheterMedtronic, Inc. · 2019 · 2 generations on3descendants
- K242276CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)Vantis Vascular, Inc. · 2024 · 3 generations on1descendant
- K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter ExtensionSeigla Medical, Inc. · 2022 · 2 generations on1descendant
- K210110GuidionImds Operations B.V. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −6 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −5 | K022138 | Spectranetics 0.035 Support Catheter, Model 518-028 | Spectranetics Corp. | 2002 | — |
| −4 | K033678 | Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… | Spectranetics Corp. | 2004 | — |
| −3 | K052258 | Vascular Solutions Skyway Support Catheter | Vascular Solutions, Inc. | 2005 | — |
| −2 | K082337 | Minnie Support Catheter | Vascular Solutions, Inc. | 2009 | — |
| −1 | K091750 | Guideliner Catheter, Models 5571, 5572, 5573 | Vascular Solutions, Inc. | 2009 | — |
| 0 (this device) | K112082 | Guideliner V2 Catheter | Vascular Solutions, Inc. | 2011 | — |
| +1 | K172090 | GuideLiner V3 Catheter | Vascular Solutions, Inc. | 2017 | — |
| +2 | K183353 | Telescope Guide Extension Catheter | Medtronic, Inc. | 2019 | — |
| +3 | K242276 | CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) | Vantis Vascular, Inc. | 2024 | — |
| +2 | K220691 | LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension | Seigla Medical, Inc. | 2022 | — |
| +2 | K210110 | Guidion | Imds Operations B.V. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K091750 | Guideliner Catheter, Models 5571, 5572, 5573Summary page 1…iner 0 V2 catheter Common / Usual Name catheter Classification Name 21 CFR 870.1250, percutaneous catheter Predicate Device GuideLiner catheter (K091750 - Vascular Solutions, Inc.) Device Description The GuideLiner V2 is a single-lumen catheter offered in four sizes (5.SF, 617,… | 2009 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 17, 2012 | Not classified | Z-1655-2012 | Material/Component Contamination | Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This… |
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 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 13 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K172090 (Vascular Solutions, Inc., 2017) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K091750.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112082: Guideliner V2 Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112082
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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