510(k) · Cleared
ClearedAsahi Corsair Microcatheter
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 Feb 3, 2009 as substantially equivalent to K062885 (Asahi Intecc Co., Ltd., 2007) and 2 other predicates after a 105-day review. Its family tree reaches back 6 generations to 2000. 33 later devices descend from it.
- Decided
- Feb 3, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001992 (2000). 13 ancestors in all, the oldest K945904 (1995). 33 later devices descend from it, 6 citing it directly.
- 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 backK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
- This deviceK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
- Descendant · cites it directly · 20 of its ownK151103 ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015
- Descendant · cites it directly · 11 of its ownK161126 ASAHI Corsair ProAsahi Intecc Co., Ltd. · 2016
- Descendant · cites it directly · 9 of its ownK112035 Valet Micro CatheterVolcano Corporation · 2012
- Descendant · cites it directly · 7 of its ownK171933 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair…Asahi Intecc Co., Ltd. · 2018
- Descendant · 2 generations on · 6 of its ownK141649 Spex Support CatheterReflow Medical · 2014
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K151103ASAHI Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2015 · cites it directly20descendants
- K161126ASAHI Corsair ProAsahi Intecc Co., Ltd. · 2016 · cites it directly11descendants
- K112035Valet Micro CatheterVolcano Corporation · 2012 · cites it directly9descendants
- K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd. · 2018 · cites it directly7descendants
- K141649Spex Support CatheterReflow Medical · 2014 · 2 generations on6descendants
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 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
| 0 (this device) | K083127 | Asahi Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2009 | — |
| +1 | K151103 | ASAHI Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2015 | — |
| +1 | K161126 | ASAHI Corsair Pro | Asahi Intecc Co., Ltd. | 2016 | — |
| +1 | K112035 | Valet Micro Catheter | Volcano Corporation | 2012 | — |
| +1 | K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro… | Asahi Intecc Co., Ltd. | 2018 | — |
| +2 | K141649 | Spex Support Catheter | Reflow Medical | 2014 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K062885 | Stride MicrocatheterSummary page 1…Percutaneous Catheter DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQy PREDICATE DEVICE: Asahi Stride Microcatheter - K062885 Asahi Tornus Catheter - K051772 Boston Scientific- Tracker Excel - 14 pre-shaped Micr… | 2007 |
| * | K051772 | Asahi Tornus Support CatheterSummary page 1…per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQy PREDICATE DEVICE: Asahi Stride Microcatheter - K062885 Asahi Tornus Catheter - K051772 Boston Scientific- Tracker Excel - 14 pre-shaped Microcatheter - K050599 DESCRIPT… | 2005 |
| * | K050599 | Tracker Excel -14 Pre-Shaped MicrocatheterSummary page 1…062885 Asahi Tornus Catheter - K051772 Boston Scientific- Tracker Excel - 14 pre-shaped Microcatheter - K050599 DESCRIPTION OF THE DEVICE SUBJECT TOPREMARKET NOTIFICATION: The ASAHI Corsair Microcatheter consists of distal tip and a shaf… | 2005 |
What descends from it? (33)
See all 336 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151103 | ASAHI Corsair Microcatheter | 2015 | 20 |
| K161126 | ASAHI Corsair Pro | 2016 | 11 |
| K112035 | Valet Micro Catheter | 2012 | 9 |
| K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter | 2018 | 7 |
| K171176 | M-CATH Microcatheter | 2017 | 0 |
| K134031 | Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation… | 2014 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K151103 (Asahi Intecc Co., Ltd., 2015) has gone furthest, with 20 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 Asahi Corsair Microcatheter is intended to provide support to facilitate the placement of Guide wires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083127: Asahi Corsair Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083127
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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