510(k) · Cleared
ClearedMicrus Microcatheter, Courier Flex, Model MSF 170000-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micrus Endovascular Corporation · DQO Catheter, Intravascular, Diagnostic
Cleared on May 6, 2009 as substantially equivalent to K060116 (Micrus Endovascular Corporation, 2006) after a 126-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- May 6, 2009
- Review
- 126 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960806 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 2 generations backK032624 Micrus MicrocatheterMicrus Corp. · 2003
- 1 generation backK060116 Micrus Courier MicrocathetersMicrus Endovascular Corporation · 2006
- This deviceK083922 Micrus Microcatheter, Courier Flex, Model MSF 170000-00Micrus Endovascular Corporation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −2 | K032624 | Micrus Microcatheter | Micrus Corp. | 2003 | — |
| −1 | K060116 | Micrus Courier Microcatheters | Micrus Endovascular Corporation | 2006 | — |
| 0 (this device) | K083922 | Micrus Microcatheter, Courier Flex, Model MSF 170000-00 | Micrus Endovascular Corporation | 2009 | — |
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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K060116 | Micrus Courier MicrocathetersSummary page 1…r Product Code: DQO Generic/Common Name: Catheter, Intravascular, Diagnostic (21CFR § 870.1200) PREDICATE DEVICES 510(k) no. K060116, Courier Microcatheter, May 12, 2006 INTENDED USE Micrus Courier Flex Microcatheters are intended to aid in the delivery of dia… | 2006 |
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 13 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K060116.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
Micrus Courier Flex Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083922 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083922: Micrus Microcatheter, Courier Flex, Model MSF 170000-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083922
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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