510(k) · Cleared
ClearedWildcat 7F Guidewire Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avinger, Inc. · DQY Catheter, Percutaneous
Cleared on Feb 2, 2009 as substantially equivalent to K060745 (Asahi Intecc Co., Ltd., 2006) and 1 other predicate after an 84-day review. Its family tree reaches back 6 generations to 2000. 1 of the 45 devices in its family, counting itself, has a Class I recall. 21 later devices descend from it.
- Decided
- Feb 2, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001992 (2000). 23 ancestors in all, the oldest K861606 (1986). 21 later devices descend from it, 2 citing it directly. 1 of the 45 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 5 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 4 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 3 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 2 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 1 generation backK060745 Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006
- This deviceK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
- Descendant · cites it directly · 18 of its ownK102022 Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010
- Descendant · 2 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011
- Descendant · 3 generations on · 14 of its ownK122380 Ocelot SystemAvinger, Inc. · 2012
- Descendant · 4 generations on · 12 of its ownK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
- Descendant · 4 generations on · 7 of its ownK140185 Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K060327 Vascular Solutions Twin-Pass Dual Access…2 generations back · 2006
Most influential descendants
Showing 5 of 21 · See all- K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc. · 2010 · cites it directly18descendants
- K111338Wildcat CatheterAvinger, Inc. · 2011 · 2 generations on17descendants
- K122380Ocelot SystemAvinger, Inc. · 2012 · 3 generations on14descendants
- K123532Ocelot Pixl CatheterAvinger, Inc. · 2012 · 4 generations on12descendants
- K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −5 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −4 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −3 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −2 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −1 | K060745 | Asahi Tornus Support Catheter with Torque Device Accessory | Asahi Intecc Co., Ltd. | 2006 | — |
| 0 (this device) | K083313 | Wildcat 7F Guidewire Support Catheter | Avinger, Inc. | 2009 | — |
| +1 | K102022 | Wildcat 6F Guidewire Support Catheter Model W400L and W400S | Avinger, Inc. | 2010 | — |
| +2 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
| +3 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
| +4 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
| +4 | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console | Avinger, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 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 |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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.
1 device in this family has 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? (2)
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 |
|---|---|---|---|
| * | K060745 | Asahi Tornus Support Catheter with Torque Device AccessorySummary page 1…lassification Name: Percutaneous Catheter (21 CFR §870.1250) Product Code: DQY Equivalent Device(s): · Asahi Tornus Support Catheter (K060745) manufactured by Asahi Intecc Co., Ltd. * GOPHER Support Catheter… | 2006 |
| * | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Summary page 1…Asahi Tornus Support Catheter (K060745) manufactured by Asahi Intecc Co., Ltd. * GOPHER Support Catheter (K070372) manufactured by Vascular Solutions, Inc. Confidential… | 2007 |
What descends from it? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 23 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K102022 (Avinger, Inc., 2010) has gone furthest, with 18 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Wildcat 7F Guidewire Support Catheter is intended to be used to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline/contrast.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083313 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083313: Wildcat 7F Guidewire Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083313
Report an extraction error
Are you the manufacturer?
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