510(k) · Cleared
ClearedWingman 14, Wingman 14C, Wingman 18, Wingman 35
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflow Medical · DQY Catheter, Percutaneous
Cleared on Feb 20, 2020 as substantially equivalent to K120533 (Bridgepoint Medical, 2012) after a 59-day review. Its family tree reaches back 11 generations to 1994. 3 of the 61 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Feb 20, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K931794 (1994). 59 ancestors in all, the oldest K884647 (1989). 1 later device descends from it, 1 citing it directly. 3 of the 61 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- 7 generations between
- 3 generations backK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
- 2 generations backK120129 Mantaray CatheterBridgepoint Medical · 2012
- 1 generation backK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
- This deviceK193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020
- Descendant · cites it directly · 0 of its ownK262013 Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- 10 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
- 9 generations backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
- 8 generations backK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
- 7 generations backK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
- 6 generations backK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
- 5 generations backK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
- 4 generations backK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
- 3 generations backK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
- 2 generations backK120129 Mantaray CatheterBridgepoint Medical · 2012
- 1 generation backK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
- This deviceK193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K262013Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931794 | Marinr Series EP Diagnostic Catheters | Medtronic Cardiorhythm | 1994 | — |
| −10 | K974683 | Naviport Deflectable Tip Guiding Catheter | Cardima, Inc. | 1999 | — |
| −9 | K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664 | Biocardia, Inc. | 2002 | — |
| −8 | K040922 | Venture Wire Control Catheter | Velocimed, Inc. | 2004 | Class I |
| −7 | K042910 | Venture Wire Control Catheter, Model WCC | Velocimed, Inc. | 2004 | Class I |
| −6 | K061843 | Venture Wire Control Catheter, Model WCC | St Jude Medical | 2006 | Class I |
| −5 | K080987 | Bridgepoint Medical Stingray Device and Accessories | Bridgepoint Medical | 2009 | 1 |
| −4 | K101591 | Stingray Orienting Balloon Catheter | Bridgepoint Medical | 2010 | 1 |
| −3 | K111963 | Bridgepoint Medical Mantaray (TM) Catheter | Bridgepoint Medical | 2011 | — |
| −2 | K120129 | Mantaray Catheter | Bridgepoint Medical | 2012 | — |
| −1 | K120533 | Bigboss Catheters Mantatay Catheter Mantaray Guidewires | Bridgepoint Medical | 2012 | — |
| 0 (this device) | K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical | 2020 | — |
| +1 | K262013 | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 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 |
|---|---|---|---|
| * | K120533 | Bigboss Catheters Mantatay Catheter Mantaray GuidewiresSummary page 4…Regulatory Class: 2 Product Code: PDU, DQY Legally marketed device Predicate Device: Medtronic Viance Crossing Catheter K120533 to which your firm is Reference Devices: Wingman Crossing Catheter claiming equivalence K132420 (Wingman 14)… | 2012 |
| † | K132420 | Wingman Extendable Tip Support Catheter | 2013 |
| † | K190393 | Wingman 14C Crossing Catheter | 2019 |
| † | K160848 | Wingman 18 Crossing Catheter | 2016 |
| † | K173661 | Wingman 35 Crossing Catheter | 2018 |
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 |
|---|---|---|---|
| K262013 | Kiba CTO Crossing Catheter | 2026 | 0 |
Has anything in its family been recalled? (3 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.
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 10 of the 59 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K262013 (Reflow Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K120533.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Crossing Catheters (14/14C/18/35) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placement of diagnostic/ interventional devices beyond peripheral stenotic lesions (including chronic total occlusions [CTOs]) and provide a…
Read the full statement (150 words)
The Wingman Crossing Catheters (14/14C/18/35) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placement of diagnostic/ interventional devices beyond peripheral stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman 14, 18, & 35 Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature. The Wingman 14C Crossing Catheter is contraindicated for use in the cerebral vasculature.
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/K193596 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193596: Wingman 14, Wingman 14C, Wingman 18, Wingman 35.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193596
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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