510(k) · Cleared
Recalled · Class II · 2022Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC Flow Directed Micro Catheter, Reba
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · KRA Catheter, Continuous Flush
Cleared on Dec 9, 2009 as substantially equivalent to K993672 (Micro Therapeutics, Inc., 2000) and 9 other predicates after a 2-day review. Its family tree reaches back 5 generations to 1998. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 9, 2009
- Review
- 2 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 2
- Predicates
- 10
Its longest line of descent runs back 5 generations to K974473 (1998). 14 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK974473 Easy Rider Micro CatheterMicro Therapeutics, Inc. · 1998
- 4 generations backK993672 Rebar Micro Catheter, Models 105-5080, 105-5086Micro Therapeutics, Inc. · 2000
- 3 generations backK030688 Echelon Micro Catheter, Model 105-5092-150Micro Therapeutics, Inc. · 2003 · Recalled
- 2 generations backK031992 Echelon Micro Catheter, Model 105-5091Micro Therapeutics, Inc. · 2003
- 1 generation backK042187 Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro…Micro Therapeutics, Inc. · 2004
- This deviceK093750 Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro…Ev3, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK210114 Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021
- Descendant · 2 generations on · 0 of its ownK243534 Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025
- Descendant · cites it directly · 0 of its ownK202318 Marathon Flow Directed Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020
Most influential descendants
Showing 3 of 3 · See all- K210114Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular · 2021 · cites it directly1descendant
- K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025 · 2 generations on0descendants
- K202318Marathon Flow Directed Micro CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974473 | Easy Rider Micro Catheter | Micro Therapeutics, Inc. | 1998 | — |
| −4 | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086 | Micro Therapeutics, Inc. | 2000 | — |
| −3 | K030688 | Echelon Micro Catheter, Model 105-5092-150 | Micro Therapeutics, Inc. | 2003 | 2 |
| −2 | K031992 | Echelon Micro Catheter, Model 105-5091 | Micro Therapeutics, Inc. | 2003 | — |
| −1 | K042187 | Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter… | Micro Therapeutics, Inc. | 2004 | — |
| 0 (this device) | K093750 | Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter… | Ev3, Inc. | 2009 | — |
| +1 | K210114 | Rebar Micro Catheter | Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular | 2021 | — |
| +2 | K243534 | Micro Catheter | Suzhou Zenith Vascular SciTech Limited | 2025 | — |
| +1 | K202318 | Marathon Flow Directed Micro Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 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 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? (10)
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 |
|---|---|---|---|
| * | K993672 | Rebar Micro Catheter, Models 105-5080, 105-5086Summary page 1…Flush Common Name: Micro Catheter Predicate Devices - 510(k) References Rebar~m-14 Micro Catheter K993672 Rebarwm-18, RebarO"-27 Micro Catheter K001966 Rebar~m-1 0 Micro Catheter… | 2000 |
| * | K001966 | Rebar Micro Catheter: Rebar-18 [2.3F], 110 CM, 130 CM, 153 CM, Single Marker Band and…Summary page 1…Devices - 510(k) References Rebar~m-14 Micro Catheter K993672 Rebarwm-18, RebarO"-27 Micro Catheter K001966 Rebar~m-1 0 Micro Catheter K002723 Ultraflowt m HPC Flow Directed Micro Catheter… | 2000 |
| * | K002723 | Rebar Micro Catheter: Rebar-10 (1.7F), 153 CM, Dual Marker Bands; Rebar Micro Catheter…Summary page 1…K993672 Rebarwm-18, RebarO"-27 Micro Catheter K001966 Rebar~m-1 0 Micro Catheter K002723 Ultraflowt m HPC Flow Directed Micro Catheter K0241 18 Nauticat m Micro Catheter… | 2000 |
| * | K024118 | Ultraflow HPC Flow Directed Micro Catheter, Models 105-5065 and 105-5066Summary page 1…K001966 Rebar~m-1 0 Micro Catheter K002723 Ultraflowt m HPC Flow Directed Micro Catheter K0241 18 Nauticat m Micro Catheter K024122 Marathon Tm Flow Directed Micro Catheter… | 2003 |
| * | K024122 | Nautica Micro Catheter, Model 105-5094-153Summary page 1…K002723 Ultraflowt m HPC Flow Directed Micro Catheter K0241 18 Nauticat m Micro Catheter K024122 Marathon Tm Flow Directed Micro Catheter .K034036 Echelon Tm-14 Micro Catheter… | 2003 |
| * | K034036 | Marathon Flow Directed Micro Catheter, Model 105-5055Summary page 1…theter K0241 18 Nauticat m Micro Catheter K024122 Marathon Tm Flow Directed Micro Catheter .K034036 Echelon Tm-14 Micro Catheter K030688 Echelon Tm-10 Micro Catheter… | 2004 |
| * | K030688 | Echelon Micro Catheter, Model 105-5092-150Summary page 1…K024122 Marathon Tm Flow Directed Micro Catheter .K034036 Echelon Tm-14 Micro Catheter K030688 Echelon Tm-10 Micro Catheter K031992 Echelont rm-10, Echelon TM-14 Tip Shape Micro… | 2003 |
| * | K031992 | Echelon Micro Catheter, Model 105-5091Summary page 1…r .K034036 Echelon Tm-14 Micro Catheter K030688 Echelon Tm-10 Micro Catheter K031992 Echelont rm-10, Echelon TM-14 Tip Shape Micro Catheter K042187 Echelon Tm Micro Catheter… | 2003 |
| * | K042187 | Echelon 10,45 Tip Shape Micro Catheter Echelon 10,90 Tip Shape Micro Catheter, Echelon…Summary page 1…K030688 Echelon Tm-10 Micro Catheter K031992 Echelont rm-10, Echelon TM-14 Tip Shape Micro Catheter K042187 Echelon Tm Micro Catheter K051 990 Description of the Device Subject to Premarke… | 2004 |
| * | K051990 | Echelon Micro CatheterSummary page 1…K031992 Echelont rm-10, Echelon TM-14 Tip Shape Micro Catheter K042187 Echelon Tm Micro Catheter K051 990 Description of the Device Subject to Premarket Notification The MTI/ev3 micro catheters are single-lumen, end-hol… | 2006 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2022 | Class II | Z-1556-2022 | Under Investigation by firm | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| Jun 30, 2022 | Class II | Z-1557-2022 | Under Investigation by firm | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K210114 (Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular, 2021) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K993672.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy. The UltraFlow HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the…
Read the full statement (174 words)
The Rebar Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The UltraFlow HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.
The Nautica Micro Catheter is intended to access peripheral and neurovasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. Not intended for use in the coronary vasculature.
The Marathon Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
The EchelonTM Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093750: Echelon Micro Catheter, Marathon Micro Catheter, Nautica Micro Catheter Ultraflow HPC Flow Directed Micro Catheter, Reba.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093750
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