510(k) · Cleared
Recalled · Class I · 2017Wingman Extendable Tip Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflow Medical · DQY Catheter, Percutaneous
Cleared on Sep 30, 2014 as substantially equivalent to K132420 (Reflow Medical, 2013) after a 111-day review. Its family tree reaches back 10 generations to 2000. 2 of the 24 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Sep 30, 2014
- Review
- 111 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001992 (2000). 21 ancestors in all, the oldest K935425 (1994). 2 later devices descend from it, 2 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 6 generations between
- 3 generations backK101479 Wingman Extendable Tip Support CatheterReflow Medical · 2010
- 2 generations backK120178 Wingman Extendable Tip Support CatheterReflow Medical · 2012
- 1 generation backK132420 Wingman Extendable Tip Support CatheterReflow Medical · 2013
- This deviceK141547 Wingman Extendable Tip Support CatheterReflow Medical · 2014
- Descendant · cites it directly · 0 of its ownK173661 Wingman 35 Crossing CatheterReflow Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK151880 Wingman Crossing CatheterReflow Medical · 2015
Show all 10 generations
- Root · 10 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 9 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 8 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 7 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 6 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 5 generations backK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
- 4 generations backK091345 Gopher Gold Catheter, Model 5620Vascular Solutions, Inc. · 2009
- 3 generations backK101479 Wingman Extendable Tip Support CatheterReflow Medical · 2010
- 2 generations backK120178 Wingman Extendable Tip Support CatheterReflow Medical · 2012
- 1 generation backK132420 Wingman Extendable Tip Support CatheterReflow Medical · 2013
- This deviceK141547 Wingman Extendable Tip Support CatheterReflow Medical · 2014
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…6 generations back · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −9 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −8 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −7 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −6 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −5 | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| −4 | K091345 | Gopher Gold Catheter, Model 5620 | Vascular Solutions, Inc. | 2009 | — |
| −3 | K101479 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2010 | — |
| −2 | K120178 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2012 | — |
| −1 | K132420 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2013 | — |
| 0 (this device) | K141547 | Wingman Extendable Tip Support Catheter | Reflow Medical | 2014 | — |
| +1 | K173661 | Wingman 35 Crossing Catheter | Reflow Medical, Inc. | 2018 | — |
| +1 | K151880 | Wingman Crossing Catheter | Reflow Medical | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K132420 | Wingman Extendable Tip Support CatheterSummary page 4…ME: DEVICE Class 2, per 21 CFR 870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICES: Wingman Extendable Support Catheter (K132420) Substantially Equivalent To: The modified Wingman Extendable Tip Support Catheter is substantially equivalent in intended use,… | 2013 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2017 | Class I | Z-1898-2017 | Under Investigation by firm | ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment. |
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 · 6 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K173661 (Reflow Medical, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132420.
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 Wingman Extendable Tip Support 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 mterventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
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/K141547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141547: Wingman Extendable Tip Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141547
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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