510(k) · Cleared
ClearedFineCross M3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ashitaka Factory of Terumo Corporation · DQY Catheter, Percutaneous
Cleared on Mar 3, 2021 as substantially equivalent to K082519 (Terumo Medical Corp., 2008) after a 92-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Mar 3, 2021
- Review
- 92 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001992 (2000). 10 ancestors in all, the oldest K945904 (1995). No later device cites it as a predicate yet.
- 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 backK082519 Finecross MG Coronary Micro-Guide CatheterTerumo Medical Corp. · 2008
- This deviceK203521 FineCross M3Ashitaka Factory of Terumo Corporation · 2021
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 | K082519 | Finecross MG Coronary Micro-Guide Catheter | Terumo Medical Corp. | 2008 | — |
| 0 (this device) | K203521 | FineCross M3 | Ashitaka Factory of Terumo Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 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? (1)
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 |
|---|---|---|---|
| * | K082519 | Finecross MG Coronary Micro-Guide CatheterSummary page 5…lassification: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is: Predicate Device: K082519 – FINECROSS MG Coronary Micro-Guide catheter, manufactured by Ashitaka Factory of Terumo Corporation. Reference Device… | 2008 |
| † | K152447 | ASAHI Caravel | 2016 |
| † | K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 10 ancestors has a recall.
- 3 other devices also cite its predicate K082519.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 product (FineCross M3) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.
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/K203521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203521: FineCross M3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203521
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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