510(k) · Cleared
ClearedFinecross MG Coronary Micro-Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · KRA Catheter, Continuous Flush
Cleared on Sep 26, 2008 as substantially equivalent to K972518 (Cordis Neurovascular, Inc., 1997) and 1 other predicate after a 24-day review. Its family tree reaches back 5 generations to 2000. 9 later devices descend from it.
- Decided
- Sep 26, 2008
- Review
- 24 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001992 (2000). 9 ancestors in all, the oldest K945904 (1995). 9 later devices descend from it, 4 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 deviceK082519 Finecross MG Coronary Micro-Guide CatheterTerumo Medical Corp. · 2008
- Descendant · cites it directly · 4 of its ownK112281 Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire…Trireme Medical, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK121402 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK122070 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK130414 Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire…Trireme Medical, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK111263 Cxi TriforceCook Incorporated · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc. · 2011 · cites it directly4descendants
- K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc. · 2012 · 2 generations on3descendants
- K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc. · 2012 · 2 generations on2descendants
- K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc. · 2013 · 3 generations on1descendant
- K111263Cxi TriforceCook Incorporated · 2011 · cites it directly1descendant
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) | K082519 | Finecross MG Coronary Micro-Guide Catheter | Terumo Medical Corp. | 2008 | — |
| +1 | K112281 | Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx… | Trireme Medical, Inc. | 2011 | — |
| +2 | K121402 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta… | Trireme Medical, Inc. | 2012 | — |
| +2 | K122070 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta… | Trireme Medical, Inc. | 2012 | — |
| +3 | K130414 | Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta… | Trireme Medical, Inc. | 2013 | — |
| +1 | K111263 | Cxi Triforce | Cook Incorporated | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 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 KRA? 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 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 |
|---|---|---|---|
| * | K972518 | Transit/Rapidtransit/Speedster/Prowler Infusion CatheterSummary page 1…Neurovascular Inc. and Asahi Intecc Co LTD, respectfully. The predicate devices have been cleared through the premarket notification process, Rapidtransit K9725 18 and Tornus K05 1772. C. INTENDED USE The product (FinecrossrM MG) is intended to be percutaneously introdu… | 1997 |
| * | K051772 | Asahi Tornus Support CatheterSummary page 1…d Asahi Intecc Co LTD, respectfully. The predicate devices have been cleared through the premarket notification process, Rapidtransit K9725 18 and Tornus K05 1772. C. INTENDED USE The product (FinecrossrM MG) is intended to be percutaneously introduced into blood vesse… | 2005 |
What descends from it? (9)
4 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 8 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K112281 (Trireme Medical, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K972518.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
What is it indicated for?
The product (FinecrossT ' MG) 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 the purpose of angiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082519: Finecross MG Coronary Micro-Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082519
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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