510(k) · Cleared
ClearedTurnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, LLC · DQY Catheter, Percutaneous
Cleared on Feb 9, 2022 as substantially equivalent to K171933 (Asahi Intecc Co., Ltd., 2018) after a 209-day review. Its family tree reaches back 14 generations to 1989. 1 later device descends from it.
- Decided
- Feb 9, 2022
- Review
- 209 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K890505 (1989). 41 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 10 generations between
- 3 generations backK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- 2 generations backK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
- 1 generation backK171933 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair…Asahi Intecc Co., Ltd. · 2018
- This deviceK212211 Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter…Vascular Solutions, LLC · 2022
- Descendant · cites it directly · 0 of its ownK220647 GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271)…Vascular Solutions, LLC · 2022
Show all 14 generations
- Root · 14 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 13 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 12 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 11 generations backK022762 Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000…Jomed, Inc. · 2002
- 10 generations backK031277 Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc. · 2003
- 9 generations backK032615 Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd. · 2003
- 8 generations backK043422 Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd. · 2005
- 7 generations backK062186 Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd. · 2006
- 6 generations backK070945 Asahi Ptca Guide WireAsahi Intecc Co., Ltd. · 2008
- 5 generations backK100578 Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd. · 2010
- 4 generations backK122469 Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi…Asahi Intecc Co., Ltd. · 2013
- 3 generations backK133865 Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd. · 2014
- 2 generations backK153106 ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd. · 2016
- 1 generation backK171933 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair…Asahi Intecc Co., Ltd. · 2018
- This deviceK212211 Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter…Vascular Solutions, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…Vascular Solutions, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −13 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −12 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −11 | K022762 | Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000… | Jomed, Inc. | 2002 | — |
| −10 | K031277 | Jowire Asahi Ptca Catheter Guide Wires, Models… | Jomed, Inc. | 2003 | — |
| −9 | K032615 | Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300 | Asahi Intecc Co., Ltd. | 2003 | — |
| −8 | K043422 | Asahi Ptca Guide Wire, J Shape Series | Asahi Intecc Co., Ltd. | 2005 | — |
| −7 | K062186 | Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300J | Asahi Intecc Co., Ltd. | 2006 | — |
| −6 | K070945 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | 2008 | — |
| −5 | K100578 | Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301S | Asahi Intecc Co., Ltd. | 2010 | — |
| −4 | K122469 | Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ | Asahi Intecc Co., Ltd. | 2013 | — |
| −3 | K133865 | Asahi Gaia First, Second, Third | Asahi Intecc Co., Ltd. | 2014 | — |
| −2 | K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-R | Asahi Intecc Co., Ltd. | 2016 | — |
| −1 | K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro… | Asahi Intecc Co., Ltd. | 2018 | — |
| 0 (this device) | K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike… | Vascular Solutions, LLC | 2022 | — |
| +1 | K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast… | Vascular Solutions, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2007 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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.
Planning a device in DQY? 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 |
|---|---|---|---|
| * | K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterSummary page 4…TrapLiner catheter Common / Usual Name Catheter Classification Name 21 CFR 870.1250, DQY, Percutaneous catheter, Class II Predicate Device K171933, Asahi Corsair Pro microcatheter (Asahi Intecc Co., LTD) Reference Devices K191560, Turnpike catheter (Vascular Solutio… | 2018 |
| † | K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | 2019 |
| † | K172090 | GuideLiner V3 Catheter | 2017 |
| † | K161901 | TrapLiner catheter | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)… | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 41 ancestors has a recall.
- Of its descendants, K220647 (Vascular Solutions, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K171933.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Turnpike catheters: The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/ deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO). GuideLiner V3 catheter: GuideLiner catheters are intended to be used in conjunction with guide…
Read the full statement (155 words)
Turnpike catheters: The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/ deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO).
GuideLiner V3 catheter: GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).
TrapLiner catheter: The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo coronary chronic total occlusions (CTO).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212211: Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212211
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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