510(k) · Cleared
ClearedMicrus Courier Microcatheters
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 12, 2006 as substantially equivalent to K032624 (Micrus Corp., 2003) after a 115-day review. Its family tree reaches back 2 generations to 1996. 18 later devices descend from it.
- Decided
- May 12, 2006
- Review
- 115 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960806 (1996). 18 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 1 generation backK032624 Micrus MicrocatheterMicrus Corp. · 2003
- This deviceK060116 Micrus Courier MicrocathetersMicrus Endovascular Corporation · 2006
- Descendant · cites it directly · 7 of its ownK061963 Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00…Micrus Endovascular Corporation · 2006
- Descendant · 2 generations on · 6 of its ownK070456 Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007
- Descendant · 3 generations on · 5 of its ownK072526 Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007
- Descendant · 3 generations on · 4 of its ownK161921 SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK080861 Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K061963Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00…Micrus Endovascular Corporation · 2006 · cites it directly7descendants
- K070456Micrus Courier Enzo Microcatheter 0.017Micrus Endovascular Corporation · 2007 · 2 generations on6descendants
- K072526Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation · 2007 · 3 generations on5descendants
- K161921SwiftNINJA MicrocatheterMerit Medical Systems, Inc. · 2016 · 3 generations on4descendants
- K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −1 | K032624 | Micrus Microcatheter | Micrus Corp. | 2003 | — |
| 0 (this device) | K060116 | Micrus Courier Microcatheters | Micrus Endovascular Corporation | 2006 | — |
| +1 | K061963 | Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00… | Micrus Endovascular Corporation | 2006 | — |
| +2 | K070456 | Micrus Courier Enzo Microcatheter 0.017 | Micrus Endovascular Corporation | 2007 | — |
| +3 | K072526 | Micrus Courier Enzo Microcatheter 0.0190 | Micrus Endovascular Corporation | 2007 | — |
| +3 | K161921 | SwiftNINJA Microcatheter | Merit Medical Systems, Inc. | 2016 | — |
| +1 | K080861 | Micrus Ascent Occlusion Balloon Catheter | Micrus Endovascular Corporation | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K032624 | Micrus MicrocatheterSummary page 1…Device Class: 2 C. Predicate Device(s) Number Description C~learance Date K(032624 Micrus Microcatheter, Concourse-14 ISept 10, 2003 D. Device Description The Micrus Microcathe… | 2003 |
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061963 | Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00… | 2006 | 7 |
| K080861 | Micrus Ascent Occlusion Balloon Catheter | 2008 | 4 |
| K113819 | Mongoose Angiographic Catheter | 2012 | 1 |
| K112828 | Revive Intermediate Catheter (Revive IC) | 2011 | 0 |
| K092702 | Micrus Microcatheter, Model Courier 270 | 2009 | 0 |
| K083922 | Micrus Microcatheter, Courier Flex, Model MSF 170000-00 | 2009 | 0 |
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 10 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061963 (Micrus Endovascular Corporation, 2006) has gone furthest, with 7 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.
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/K060116 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060116: Micrus Courier Microcatheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060116
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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