510(k) · Cleared
ClearedWingman 35 Crossing Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflow Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Apr 18, 2018 as substantially equivalent to K141547 (Reflow Medical, 2014) after a 140-day review. Its family tree reaches back 11 generations to 2000. 2 of the 23 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 18, 2018
- Review
- 140 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001992 (2000). 22 ancestors in all, the oldest K935425 (1994). No later device cites it as a predicate yet. 2 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 7 generations between
- 3 generations backK120178 Wingman Extendable Tip Support CatheterReflow Medical · 2012
- 2 generations backK132420 Wingman Extendable Tip Support CatheterReflow Medical · 2013
- 1 generation backK141547 Wingman Extendable Tip Support CatheterReflow Medical · 2014 · Recalled (Class I)
- This deviceK173661 Wingman 35 Crossing CatheterReflow Medical, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 10 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 9 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 8 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 7 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 6 generations backK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
- 5 generations backK091345 Gopher Gold Catheter, Model 5620Vascular Solutions, Inc. · 2009
- 4 generations backK101479 Wingman Extendable Tip Support CatheterReflow Medical · 2010
- 3 generations backK120178 Wingman Extendable Tip Support CatheterReflow Medical · 2012
- 2 generations backK132420 Wingman Extendable Tip Support CatheterReflow Medical · 2013
- 1 generation backK141547 Wingman Extendable Tip Support CatheterReflow Medical · 2014 · Recalled (Class I)
- This deviceK173661 Wingman 35 Crossing CatheterReflow Medical, 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 |
|---|---|---|---|---|---|
| −11 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −10 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −9 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −8 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −7 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −6 | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| −5 | K091345 | Gopher Gold Catheter, Model 5620 | Vascular Solutions, Inc. | 2009 | — |
| −4 | K101479 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2010 | — |
| −3 | K120178 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2012 | — |
| −2 | K132420 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2013 | — |
| −1 | K141547 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2014 | Class I |
| 0 (this device) | K173661 | Wingman 35 Crossing Catheter | Reflow Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
| 2007 | 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 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 |
|---|---|---|---|
| * | K141547 | Wingman Extendable Tip Support CatheterSummary page 4…heter Classification name: Percutaneous Catheter Regulatory Class: 2 Product Code: DQY III. PREDICATE DEVICE Wingman 35 Crossing Catheter (K141547) This predicate has been subject to a design-related recall IV. DEVICE DESCRIPTION The Wingman 35 Crossing Cath… | 2014 |
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.
- K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · 7 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 22 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K141547.
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 Wingman 35 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173661: Wingman 35 Crossing Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173661
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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