510(k) · Cleared
ClearedAsahi Tornus Support Catheter with Torque Device Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · DQY Catheter, Percutaneous
Cleared on Jun 23, 2006 as substantially equivalent to K051772 (Asahi Intecc Co., Ltd., 2005) and 2 other predicates after a 95-day review. Its family tree reaches back 5 generations to 2000. 22 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 95 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K001992 (2000). 12 ancestors in all, the oldest K861606 (1986). 22 later devices descend from it, 1 citing it directly.
- 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 deviceK060745 Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006
- Descendant · cites it directly · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, 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
- Descendant · 5 generations on · 12 of its ownK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · cites it directly21descendants
- 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
- K123532Ocelot Pixl CatheterAvinger, Inc. · 2012 · 5 generations on12descendants
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) | K060745 | Asahi Tornus Support Catheter with Torque Device Accessory | Asahi Intecc Co., Ltd. | 2006 | — |
| +1 | K083313 | Wildcat 7F Guidewire Support Catheter | Avinger, 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 | — |
| +5 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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.
Planning a device in DQY? 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 |
|---|---|---|---|
| * | K051772 | Asahi Tornus Support CatheterSummary page 1…Percutaneous Catheter DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Asahi Tornus Support Catheter K051772 JS Vascular Guide Wire Vise/Torque Device K032411 Boston Scientific Wireclip Torquer K003398… | 2005 |
| * | K032411 | JS Vascular Guide Wire Vise/Torque DeviceSummary page 1…1 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Asahi Tornus Support Catheter K051772 JS Vascular Guide Wire Vise/Torque Device K032411 Boston Scientific Wireclip Torquer K003398 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:… | 2003 |
| * | K003398 | Wireclip TorquerSummary page 1…TE DEVICE: Asahi Tornus Support Catheter K051772 JS Vascular Guide Wire Vise/Torque Device K032411 Boston Scientific Wireclip Torquer K003398 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The ASAHI Tomus support catheter is a device that is inten… | 2000 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083313 | Wildcat 7F Guidewire Support Catheter | 2009 | 21 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K083313 (Avinger, Inc., 2009) has gone furthest, with 21 descendants of its own.
- 9 other devices also cite its predicate K051772.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ASAHI Tornus support catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060745 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060745: Asahi Tornus Support Catheter with Torque Device Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060745
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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