510(k) · Cleared
ClearedASAHI Corsair Pro
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 Aug 25, 2016 as substantially equivalent to K151103 (Asahi Intecc Co., Ltd., 2015) and 1 other predicate after a 126-day review. Its family tree reaches back 8 generations to 2000. 11 later devices descend from it.
- Decided
- Aug 25, 2016
- Review
- 126 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K001992 (2000). 15 ancestors in all, the oldest K945904 (1995). 11 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 7 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 6 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 5 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 4 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 3 generations backK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
- 2 generations backK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
- 1 generation backK151103 ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015
- This deviceK161126 ASAHI Corsair ProAsahi Intecc Co., Ltd. · 2016
- Descendant · cites it directly · 7 of its ownK171933 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair…Asahi Intecc Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK182360 Teleport MicrocatheterOrbusneich Medical Trading, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK231608 Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK212211 Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter…Vascular Solutions, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK242588 COREPASS Modular Microcatheter (FLEX); COREPASS Modular…OrbusNeich Medical (Shenzhen) Co., Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd. · 2018 · cites it directly7descendants
- K182360Teleport MicrocatheterOrbusneich Medical Trading, Inc. · 2018 · cites it directly2descendants
- K231608Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd. · 2024 · 2 generations on1descendant
- K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…Vascular Solutions, LLC · 2022 · 2 generations on1descendant
- K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)OrbusNeich Medical (Shenzhen) Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −7 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −6 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −5 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −4 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −3 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
| −2 | K083127 | Asahi Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2009 | — |
| −1 | K151103 | ASAHI Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2015 | — |
| 0 (this device) | K161126 | ASAHI Corsair Pro | Asahi Intecc Co., Ltd. | 2016 | — |
| +1 | K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro… | Asahi Intecc Co., Ltd. | 2018 | — |
| +1 | K182360 | Teleport Microcatheter | Orbusneich Medical Trading, Inc. | 2018 | — |
| +2 | K231608 | Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024 | — |
| +2 | K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike… | Vascular Solutions, LLC | 2022 | — |
| +3 | K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
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? (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 |
|---|---|---|---|
| * | K151103 | ASAHI Corsair MicrocatheterSummary page 4…LASSIFICATION NAME: Percutaneous Catheter PRODUCT CODE DQY- Catheter, Percutaneous PREDICATE DEVICES: ASAHI Corsair Microcatheter (K151103, K083127) INTENDED USE/INDICATIONS FOR USE The ASAHI Corsair Pro is intended to provide support to facilitate the placement of… | 2015 |
| * | K083127 | Asahi Corsair MicrocatheterSummary page 4…TION NAME: Percutaneous Catheter PRODUCT CODE DQY- Catheter, Percutaneous PREDICATE DEVICES: ASAHI Corsair Microcatheter (K151103, K083127) INTENDED USE/INDICATIONS FOR USE The ASAHI Corsair Pro is intended to provide support to facilitate the placement of guide wi… | 2009 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K171933 (Asahi Intecc Co., Ltd., 2018) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K151103.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 ASAHI Corsair Pro is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature and can be used to exchange one guide wire for another. The ASAHI Corsair Pro is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculature. This device should not be used in neurovasculature.
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/K161126 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161126: ASAHI Corsair Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161126
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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