510(k) · Cleared
ClearedMiraflex High Flow Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · KRA Catheter, Continuous Flush
Cleared on Aug 8, 2008 as substantially equivalent to K060224 (Cook Incorporated, 2006) after a 144-day review. Its family tree reaches back 1 generation to 2006. 3 later devices descend from it.
- Decided
- Aug 8, 2008
- Review
- 144 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060224 (2006). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK060224 Modification to Mira-Flex 18 MicrocatheterCook Incorporated · 2006
- This deviceK080737 Miraflex High Flow MicrocatheterCook, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK101450 Cantata MicrocatheterCook, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK131772 Cantata (R) 2.9 MicrocatheterCook, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK191305 Hereaeus Poseidon MicrocatheterHeraeus Medical Components, LLC · 2019
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060224 | Modification to Mira-Flex 18 Microcatheter | Cook Incorporated | 2006 | — |
| 0 (this device) | K080737 | Miraflex High Flow Microcatheter | Cook, Inc. | 2008 | — |
| +1 | K101450 | Cantata Microcatheter | Cook, Inc. | 2010 | — |
| +2 | K131772 | Cantata (R) 2.9 Microcatheter | Cook, Inc. | 2014 | — |
| +3 | K191305 | Hereaeus Poseidon Microcatheter | Heraeus Medical Components, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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 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? (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 |
|---|---|---|---|
| * | K060224 | Modification to Mira-Flex 18 MicrocatheterSummary page 1…Microcatheter is similar in terms of intended use, materials, and technological characteristics to the predicate MiraFlexTM 18 Microcatheter cleared under 5 10(k) number K060224. Device Description: The MiraFlexTM High Flow Microcatheter is an infusion catheter with a hydrophilic coating, designed for us… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101450 | Cantata Microcatheter | 2010 | 2 |
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?
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 MiraFlexTM High Flow Microcatheter is designed for use in small vessel or
superselective anatomy for diagnostic and interventional procedures including neuro,
peripheral, or coronary use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080737: Miraflex High Flow Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080737
Report an extraction error
Are you the manufacturer?
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