510(k) · Cleared
ClearedGopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610
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 Jun 1, 2007 as substantially equivalent to K052258 (Vascular Solutions, Inc., 2005) and 2 other predicates after a 113-day review. Its family tree reaches back 5 generations to 2000. 2 of the 59 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it.
- Decided
- Jun 1, 2007
- Review
- 113 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001992 (2000). 14 ancestors in all, the oldest K935425 (1994). 44 later devices descend from it, 3 citing it directly. 2 of the 59 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 4 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 3 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 2 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 1 generation backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- This deviceK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
- Descendant · cites it directly · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
- Descendant · cites it directly · 20 of its ownK091345 Gopher Gold Catheter, Model 5620Vascular Solutions, Inc. · 2009
- Descendant · 2 generations on · 18 of its ownK102022 Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010
- Descendant · 3 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011
- Descendant · 4 generations on · 14 of its ownK122380 Ocelot SystemAvinger, Inc. · 2012
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 44 · See all- K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · cites it directly21descendants
- K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc. · 2009 · cites it directly20descendants
- K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010 · 2 generations on18descendants
- K111338Wildcat CatheterAvinger, Inc. · 2011 · 3 generations on17descendants
- K122380Ocelot SystemAvinger, Inc. · 2012 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −4 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −3 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −2 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −1 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| 0 (this device) | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| +1 | K083313 | Wildcat 7F Guidewire Support Catheter | Avinger, Inc. | 2009 | — |
| +1 | K091345 | Gopher Gold Catheter, Model 5620 | Vascular Solutions, Inc. | 2009 | — |
| +2 | K102022 | Wildcat 6F Guidewire Support Catheter Model W400L and W400S | Avinger, Inc. | 2010 | — |
| +3 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
| +4 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 1 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K052258 | Vascular Solutions Skyway Support CatheterSummary page 1…1I Classification Name: Percutaneous catheter (21 CFR 870.1250, Product Code DQY) Predicate Devices Skyway T M Support Catheter (K052258 and K060327), manufactured by Vascular Solutions, Inc. Tomus Support Catheter (KO51772), manufactured by Asahi Intecc Co., L… | 2005 |
| * | K060327 | Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterSummary page 1…lassification Name: Percutaneous catheter (21 CFR 870.1250, Product Code DQY) Predicate Devices Skyway T M Support Catheter (K052258 and K060327), manufactured by Vascular Solutions, Inc. Tomus Support Catheter (KO51772), manufactured by Asahi Intecc Co., Ltd. Device… | 2006 |
| * | K051772 | Asahi Tornus Support Catheter | 2005 |
What descends from it? (44)
See all 443 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)
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.
- K060327Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support CatheterVascular Solutions, Inc. · 2006 · Direct predicate · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
- K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 14 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K083313 (Avinger, Inc., 2009) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K052258.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Gopher Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discreet regions of the arterial and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic or therapeutic agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070372: Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070372
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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